Abaloparatide

Dosing from the Literature

Published for bone healing: one placebo-controlled trial randomized 48 adults after a pelvic fracture to the label’s 80 µg a day under the skin or placebo for 12 weeks, and healing was no better than on placebo. Not published: any dose shown to speed the healing of a fracture, a spinal fusion or a tendon in people.

The label gives one dose, for osteoporosis, and the trials below used it apart from the early dose-finding study and the patch. The animal rows give the doses of the fracture and fusion studies, with their species. These are label and trial doses, not recommendations.

What It Is

Abaloparatide is a synthetic peptide of 34 amino acids, an analog of human parathyroid hormone-related peptide, PTHrP(1-34) (Tymlos label). It shares 76% of its sequence with PTHrP(1-34) and 41% with parathyroid hormone, PTH(1-34), and the building block at position 29 is Aib, 2-methylalanine (Tymlos label; PubChem). Its formula is C174H300N56O49 and its molecular weight 3,961 daltons (Tymlos label; PubChem). It was developed under the code BA058 (NCT00542425); PubChem lists BIM-44058 as another name (PubChem).

Radius Health sponsored its development trials: a Phase 2 dose-finding study from 2007 (NCT00542425; Leder et al., 2015) and the Phase 3 ACTIVE trial from 2011 (Miller et al., 2016). FDA approved it as Tymlos on April 28, 2017, for postmenopausal women with osteoporosis at high risk for fracture (Drugs@FDA). That first label carried a boxed warning: it caused osteosarcoma, a bone cancer, in rats, and cumulative use of it and other PTH analogs for more than 2 years in a lifetime was not advised (Tymlos label, 2017). The boxed warning was removed in December 2021 (Tymlos label, 2021), and on December 19, 2022 FDA approved a second use, to increase bone density in men with osteoporosis at high risk for fracture (FDA approval letter, 2022). The current label, effective August 2026, added a warning on allergic reactions, including anaphylaxis (Tymlos label).

Europe took longer. Radius applied in 2015; in 2018 the EU’s medicines committee gave a negative opinion and confirmed it on re-examination, finding that the main trial did not satisfactorily show prevention of fractures outside the spine, that data from two study sites were unreliable because those sites had not followed good clinical practice, and that the drug’s effects on the heart, such as a faster heart rate and palpitations, were a concern (EMA, 2018; Davenport et al., 2024). A new application, supported by observational data from US patients, was authorised on December 12, 2022, as Eladynos, held by Theramex, for postmenopausal women at increased risk of fracture (EMA, 2022; Davenport et al., 2024), and Great Britain’s regulator, the MHRA, approved Eladynos for the same use on March 27, 2023, relying on the EU decision (Davenport et al., 2024). Japan had approved it on March 23, 2021, as Ostabalo, held by Teijin Pharma, for osteoporosis with a high risk of fracture (PMDA, 2021).

None of these approvals covers healing a broken bone, a spinal fusion or a tendon. That use rests on animal studies, case reports and one randomized trial (see Human Data). PubMed returns 413 records for “abaloparatide,” 31 of them tagged as randomized controlled trials, and 24 for abaloparatide with fracture healing or nonunion (searched October 4, 2026).

Mechanism of Action

The receptor, the signaling and the effects on bone markers below come from the label, cell studies, animals and the osteoporosis trials. How it affects a healing fracture in people is not known.

• PTH1 receptor (PTH1R) and cAMP — Abaloparatide activates the PTH1 receptor, the receptor through which both parathyroid hormone and PTHrP act (Hattersley et al., 2016), which switches on cAMP signaling in target cells; given once a day it stimulates new bone formation on spongy (trabecular) and dense (cortical) bone by stimulating bone-forming osteoblasts (Tymlos label). In ovariectomized rats given it for 12 months, bone mass and strength rose with the dose (Varela et al., 2017); in ovariectomized cynomolgus monkeys given it for 16 months, bone formation, bone mass and spine strength rose without a rise in bone resorption or blood calcium (Doyle et al., 2018). Both studies had Charles River Laboratories and Radius Health scientists among their authors, and Radius funded the rat study (Varela et al., 2017; Doyle et al., 2018).
• RG and R0 receptor conformations (a proposal) — In cells, abaloparatide bound more selectively than PTH(1-34) to the receptor’s RG conformation and produced a shorter cAMP response; the authors, two from Radius Health and three from Massachusetts General Hospital, offer this brief signaling as a plausible reason for its bone-building profile (Hattersley et al., 2016). A later Massachusetts General Hospital study found teriparatide, abaloparatide and a long-acting PTH engaged downstream signaling to a comparable degree at the times tested, with faster receptor recycling for abaloparatide, and suggested that differences in the body may come from pharmacokinetics, or that cell assays miss what happens in bone (Sato et al., 2021). Cryo-electron microscopy shows both peptides holding the receptor–G protein complex in similar overall shapes, with differences in the receptor’s outer domain (Zhai et al., 2022).
• Bone formation and resorption markers — In women on it for 18 months, the formation marker PINP peaked at month 1, 93% above baseline, and was still 45% above baseline at month 18, while the resorption marker CTX peaked at month 3, 26% above baseline, and was back to baseline by month 18; in men on it for 12 months, PINP peaked at 133% above baseline at month 1 and was 84% above at month 12, and CTX peaked at 46% above at month 6 and was 35% above at month 12 (Tymlos label). In human bone-forming cells exposed for 6 hours, it raised the resorption signals RANKL/OPG and M-CSF less than teriparatide did, in work by Teijin Pharma scientists (Makino et al., 2018).
• Heart and blood vessels — In 55 healthy people, heart rate rose within 15 minutes of a dose, by a mean peak of 15 beats per minute at 80 µg and 20 at 240 µg (Tymlos label). In ACTIVE, the rise 1 hour after the first dose averaged 7.9 beats per minute on abaloparatide, 5.3 on teriparatide and 1.2 on placebo (Cosman et al., 2020). The EU label says it may widen blood vessels and speed and strengthen the heartbeat (Eladynos EU label).
• In the blood — After an 80 µg injection under the skin it peaks in about half an hour, 36% of the dose reaches the blood, about 70% is bound to plasma proteins, and its half-life is about 1 hour; it is broken into peptide fragments that the kidneys clear, and in severe kidney impairment exposure (AUC) was 2.1 times that with normal kidneys (Tymlos label).

What the Research Shows

The results below are in animals. The human studies, including the fracture-healing trial, are in the next section.

• Broken and drilled bones, rats and mice — In a Radius Health study of 96 male rats with a pinned thighbone fracture, 5 or 20 µg/kg a day from the next day gave calluses with more area, more new bone and higher bridging scores than saline at 4 and 6 weeks, and stronger calluses in bending tests (Lanske et al., 2019). In an independent Swedish study, mice with a cut thighbone given 60 µg/kg of abaloparatide or 15 µg/kg of teriparatide a day for 28 days had callus densities of 47% and 38%, against 23% on saline; both drugs gave denser callus than saline but did not differ from each other (Bernhardsson & Aspenberg, 2018). The same paper’s main model was a screw set in a hole drilled in the shinbone of 96 mice, given saline or one of five doses of either drug for 10 days: the force needed to pull the screw out rose with the dose, and per microgram abaloparatide appeared about 2.5 times as potent as teriparatide, rather than the 4:1 ratio of the doses in the human comparison trial (Bernhardsson & Aspenberg, 2018). The authors note that bone density in the holes weakens the conclusion that abaloparatide is the more potent per microgram (Bernhardsson & Aspenberg, 2018). In rats given it before a thighbone osteotomy, callus formed and matured faster with abaloparatide, alone or with zoledronate, than with zoledronate alone or nothing (Kataoka et al., 2024).
• Spine defects and spinal fusion — In ovariectomized rats with holes drilled in a vertebra, 30 µg/kg a day for up to 6 weeks increased bone mineral content and strength at the defect, in a study by Teijin Pharma scientists and university groups (Makino et al., 2024). After spinal fusion in 32 male rats, 20 µg/kg a day raised a bone-formation marker, and at day 28 both sides had fused in 50% of treated rats against 25% of controls, a difference that was not significant; four of its five authors were current or former Radius employees, and Radius paid for the animal work (Arlt et al., 2021). In 24 rabbits, in a Hospital for Special Surgery study with a Radius scientist among its authors and drug from Radius, 10 of 10 treated animals fused against 5 of 11 controls by manual testing, with more bone in the fusion mass, but biomechanical tests in flexion, extension and side bending did not differ (Morse et al., 2022).
• Rotator cuff (tendon to bone) — In ovariectomized rats with chronic rotator-cuff tears that were then repaired, injections under the skin gave a failure load of 25.13 newtons at 8 weeks, against 13.36 in untreated controls, and a more mature tendon–bone junction on histology (Xu et al., 2022). No human study of abaloparatide in tendon repair turned up (PubMed, October 4, 2026).
• Bone tumors in rats — Fischer rats given 10, 25 or 50 µg/kg a day for up to 2 years developed osteosarcoma in a dose- and time-dependent way, comparable to rats given PTH(1-34) at a similar exposure, in a study with Charles River Laboratories and Radius Health scientists among its authors (Jolette et al., 2017). The label puts these doses at 4 to 28 times the human exposure at 80 µg, and the osteosarcoma rate at 0–2% in untreated rats against 87% of males and 62% of females at the top dose (Tymlos label).

Human Data

Published: the osteoporosis trials that led to its approvals, sponsored by Radius Health or, in Japan, funded by Teijin Pharma, a Phase 3 trial of a patch, one randomized trial in fracture healing, observational studies around orthopedic surgery and case reports. ClinicalTrials.gov lists 26 abaloparatide records (searched October 4, 2026).

• Phase 2 dose-finding, 222 women, 24 weeks (Leder et al., 2015) — Postmenopausal women with osteoporosis received 20, 40 or 80 µg a day, placebo or teriparatide 20 µg (NCT00542425). Spine bone density rose 2.9%, 5.2% and 6.7% with the three doses, 5.5% with teriparatide and 1.6% with placebo; total-hip gains at 40 and 80 µg were larger than with placebo and teriparatide.
• ACTIVE, Phase 3, 2,463 women, 18 months (Miller et al., 2016) — At 28 sites in 10 countries from 2011 to 2014, postmenopausal women with osteoporosis received blinded abaloparatide 80 µg (824) or placebo (821) a day, or open-label teriparatide 20 µg (818); 1,901 completed. New spine fractures occurred in 4 of 690 women with X-rays on abaloparatide, 30 of 711 on placebo and 6 of 717 on teriparatide (NCT01343004): 0.6% against 4.2%, an 86% relative reduction (Tymlos label). Fractures outside the spine occurred in 2.7% against 4.7% on placebo (p = 0.049) (Tymlos label). Spine bone density rose 9.20% on abaloparatide and 9.12% on teriparatide, total-hip density 3.44% and 2.81% (NCT01343004). Hypercalcemia, a prespecified safety endpoint, occurred in 3.4% on abaloparatide and 6.4% on teriparatide (Miller et al., 2016). Iliac-crest biopsies after 12–18 months showed normal bone structure (Moreira et al., 2017).
• ACTIVE as Europe read it (Davenport et al., 2024) — Because of good-clinical-practice concerns about one principal investigator, data from two sites were excluded, cutting the population by 16%; without them, fractures outside the spine were 2.7% on abaloparatide and 3.6% on placebo, not a significant difference (hazard ratio 0.74, 95% CI 0.38 to 1.43). The EU label reports ACTIVE in 2,070 women, with new spine fractures in 0.5% on abaloparatide and 4.2% on placebo (Eladynos EU label).
• ACTIVExtend, alendronate after it (Cosman et al., 2017; Bone et al., 2018) — 1,139 women from the abaloparatide and placebo groups went on to alendronate 70 mg a week for up to 24 months (NCT01657162). Over the full 43 months, new spine fractures occurred in 0.9% of the abaloparatide-then-alendronate group and 5.6% of the placebo-then-alendronate group, an 84% relative reduction, and an analysis for regulators found no hip fractures in the first group against five in the second (Bone et al., 2018).
• ATOM, Phase 3, 228 men, 12 months (Czerwinski et al., 2022) — Men aged 40 to 85 with osteoporosis, randomized 2:1 to 80 µg a day or placebo (NCT03512262). Bone density rose 8.48% against 1.17% at the spine, 2.14% against 0.01% at the total hip and 2.98% against 0.15% at the femoral neck; the commonest adverse events (5% or more) were injection-site reactions, dizziness, nasopharyngitis, joint pain, bronchitis, high blood pressure and headache. The label’s data for men come from this trial (Tymlos label).
• ACTIVE-J, Japan, 78 weeks (Matsumoto et al., 2022) — 212 Japanese women and men at high fracture risk received 80 µg a day or placebo (2:1); spine bone density rose 12.5% more than on placebo, and new fractures of 4 vertebrae in 3 people occurred on placebo against none on abaloparatide. Teijin Pharma funded the trial.
• The patch, Phase 3, 511 women, 12 months (Lewiecki et al., 2023) — A Radius Health–sponsored open-label trial compared a daily microstructured transdermal patch with the 80 µg injection (NCT04064411). Spine bone density rose 7.14% with the patch and 10.86% with the injection, so the patch failed its noninferiority margin of 2.0%; reactions at the application or injection site occurred in 94.4% and 70.5%. No patch has been approved (Drugs@FDA).
• Pelvic fracture healing, Phase 2 randomized trial, 48 adults (Nieves et al., 2026) — Women and men aged 50 or older, enrolled within 4 weeks of a pelvic fracture, received 80 µg a day or a matching placebo pen for 12 weeks, in an NIH-funded trial for which Radius supplied drug and placebo (NCT04249232). It planned 78 people and randomized 48 (26 to abaloparatide, 22 to placebo); 3 assigned to abaloparatide never started it. Recruitment stopped at 48 when NIH funding ended, and the authors call the results exploratory. Their mean age was 82 and 93% were women. On CT at 3 months, 39% were healed on abaloparatide and 64% on placebo (relative risk 0.61, 95% CI 0.33 to 1.12); per fracture, 47% and 53%. Physical performance improved in both groups, and neither it nor the change in pain differed between them. The authors write that the direction favored placebo, so a larger study would be unlikely to reverse it, and that bulky but unbridged callus was seen more often on abaloparatide (11 people in all, too few to test). After 3 months all were offered abaloparatide for 9 more months; 40 entered this open-label extension and 30 completed 12 months, and neither the timed get-up-and-walk test nor the performance score improved significantly from month 3 to month 12, with no difference in walking time between the original groups (Nieves et al., 2026). The same group’s trial of teriparatide on the same protocol, in 35 patients, also found no difference in CT healing or pain, but its physical-performance score was higher on teriparatide than on placebo at 2 and 3 months (Nieves et al., 2022); the group’s 2026 paper recalls that result as an improvement within the teriparatide group with no difference between the groups (Nieves et al., 2026).
• Neck (odontoid) fractures, stopped (NCT04760782) — A University of Vermont pilot gave 80 µg a day for 8 weeks, with a hard collar, to adults aged 50 or older with a type II odontoid fracture and compared them with past patients. It ended in 2023 for slow recruitment: 5 people started abaloparatide and 1 completed. That person’s CT at 3 months showed no bridging bone (0%), against a median of 3.6% (range 0–7.2%) in the 2 controls measured, and the registry notes too little statistical power for any analysis. One participant on abaloparatide died of respiratory failure, an event the investigators recorded as unrelated to the study.
• Around orthopedic surgery, observational — In an open-label study, 29 people with osteoporosis given abaloparatide for a mean 96 days before a knee replacement gained distal-femur bone density that differed from 29 untreated controls with milder bone loss by 4.6% to 7.6% at 6 and 15 months; the controls did not lose bone there (Nickel et al., 2026). A post hoc analysis of two trials found spine bone density up 4.14% in 149 men and 4.42% in 250 women after 3 months on it (VanDerwerker et al., 2026). In a national database of lumbar fusions, the odds of reoperation linked to abaloparatide (odds ratio 3.04, 95% CI 0.71 to 8.95) were not statistically significant (Khalid et al., 2025).
• Case reports of healing — A 52-year-old runner’s foot osteotomy, not united at 10 months, united 5 months after she started 80 µg a day (Nelson & Gavin, 2021). A 59-year-old man’s open ankle (pilon) fracture showed little progress for more than 8 months; within 6 weeks of starting abaloparatide, for a separate sacral fracture, bridging callus appeared, and the authors write that causality cannot be established (Nozaka et al., 2026). A 64-year-old woman who had been on 80 µg a day for 3 months before a shoulder fracture-dislocation showed bone union of the broken fragment on X-ray 16 days after surgery; the authors name both the drug and a nerve injury from the fracture as possible contributors, and the quality of the callus could not be assessed (Joko et al., 2026).

Registered and not finished: the placebo-controlled FAST-Healing trial in lumbar spinal fusion (NCT03841058), a study of abaloparatide around lumbar fusion (NCT07587775), a trial adding it to denosumab (NCT04467983), a Chinese Phase 3 of an abaloparatide injection against teriparatide (NCT06898060), and two studies that include postmenopausal women treated with it, one observational, of the drugs given before and after it (NCT06164795), and one of blood markers of response (NCT07616401). Two more have had no registry update since their planned dates passed: a bioequivalence study of a Chinese abaloparatide injection against Tymlos, still listed as not yet recruiting (NCT06753864), and a placebo-controlled Korean Phase 3 whose status the registry lists as unknown (NCT06154187). Trials in thighbone fractures above the knee (NCT04626141) and disc degeneration (NCT03708926) were withdrawn before enrolling (ClinicalTrials.gov, October 5, 2026).

The evidence meter on the Abaloparatide card reads “Controlled trials”: it counts published human data on abaloparatide itself for bone healing, and one randomized, placebo-controlled trial is published (Nieves et al., 2026). Controlled is not the same as positive: that trial found no benefit. Its approvals, in the US, the EU, Great Britain and Japan, are for treating osteoporosis in people at high or increased risk of fracture (in US men, to increase bone density), not for healing fractures (Tymlos label; Eladynos EU label; Davenport et al., 2024; PMDA, 2021).

Reconstitution & Storage

There is nothing to reconstitute in the approved product. Tymlos is a clear, colorless solution in a glass cartridge inside a prefilled pen: 3,120 µg in 1.56 mL (2,000 µg/mL), delivering 30 daily doses of 80 µg in 40 µL; needles are not included (Tymlos label). The pelvic-fracture and spinal-fusion trials used the pen and a matching placebo pen (NCT04249232; NCT03841058).

• Storage on the US label — Refrigerated at 2–8 °C before first use; after first use, up to 30 days at 20–25 °C; not frozen or heated (Tymlos label).
• Storage on the EU label — Refrigerated at 2–8 °C, not frozen; after first use or once out of the refrigerator, below 25 °C and used within 30 days (Eladynos EU label).
• Where it goes — The US label describes injection under the skin around the navel, a different spot each day at about the same time, with the first doses taken where the person can sit or lie down, because blood pressure can drop on standing (Tymlos label).
• The patch — The transdermal system in the trials carried abaloparatide coated on a microstructured array, worn on the thigh for 5 minutes once a day (NCT04064411). No patch has been approved (Drugs@FDA).
• Lab-reagent powder — Outside the pen, abaloparatide is sold as a powder for laboratory research. One chemical supplier’s product sheet lists the acetate salt as a solid, at least 95% pure, kept at −20 °C, and “for research only – not for human or veterinary diagnostic or therapeutic use” (chemical supplier’s product sheet, 2022). No study has tested such a powder in people; the rabbit fusion study used powder supplied by Radius Health (Morse et al., 2022).

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Side Effects & Risks

• Common reactions, women (ACTIVE) — More frequent than on placebo: high urine calcium 11% vs 9%, dizziness 10% vs 6%, nausea 8% vs 3%, headache 8% vs 6%, palpitations 5% vs 0.4%, fatigue 3% vs 2%, upper abdominal pain 3% vs 2%. Serious adverse events: 10% vs 11%. Stopped for adverse events: 10% vs 6%, most often for nausea (Tymlos label).
• Common reactions, men (ATOM) — Injection-site redness 13% vs 5%, dizziness 9% vs 1%, joint pain 7% vs 1%, injection-site swelling 7% vs 0%, injection-site pain 6% vs 0% (Tymlos label).
• Dizziness, low blood pressure and a fast heart — Blood pressure on standing can drop within about 4 hours of an injection; after the first dose, a drop of 20 mmHg systolic or 10 diastolic occurred in 4% of women on it and 3% on placebo, and tachycardia was reported in 2% and 1% (Tymlos label). Serious cardiac adverse events were similar on abaloparatide, teriparatide and placebo, 0.9% to 1.0% (Cosman et al., 2020). Heart effects were one of the EU’s reasons for refusing it in 2018 (EMA, 2018); the EU label lists blood pressure, cardiac status and an ECG before treatment (Eladynos EU label).
• Calcium, uric acid and kidney stones — Blood calcium of 10.7 mg/dL or more 4 hours after a dose occurred in 3% of women on it and 0.1% on placebo, and in 4% of those with mild or moderate kidney impairment; uric acid rose above normal in 25% against 6%; urine calcium-to-creatinine above 400 mg/g in 20% against 15%; kidney stones were reported in 2.1% against 1.7% (Tymlos label). Hypercalcemia was less frequent than on teriparatide, 3.4% against 6.4% (Miller et al., 2016).
• Injection site — In the first month of ACTIVE, redness 58% vs 28% on placebo, swelling 11% vs 3% and pain 10% vs 7% (Tymlos label). With the patch, site reactions reached 94.4% (Lewiecki et al., 2023).
• Antibodies and allergy — 41% of women on it for 18 months developed antibodies to abaloparatide and 26% neutralizing ones, with no clinically significant effect seen on bone density, fractures or adverse events (Tymlos label). The label added a warning in August 2026: anaphylaxis, angioedema and hives have been reported with PTH analogs, including Tymlos (Tymlos label). A kidney-transplant recipient developed two new HLA antibodies and a rise in creatinine after 5 months on it; it was stopped, and a biopsy showed no rejection (Swanson et al., 2023).
• In the healing trials — In the pelvic-fracture trial, 4 serious adverse events occurred on abaloparatide (a new sacral fracture, neurogenic bladder, chronic diarrhea and seizures) and 2 on placebo (abdominal pain and a hip fracture), none judged related to the drug; high calcium occurred 3 times in 2 people on it and 6 times in 5 on placebo (Nieves et al., 2026). In the odontoid pilot, one of 5 participants died of respiratory failure, recorded as unrelated (NCT04760782).
• Single case reports — Pseudoxanthoma elasticum, a disorder of calcified elastic tissue, appeared in the skin of a 56-year-old woman six weeks after she started it, and an eye examination found angioid streaks, breaks in a layer at the back of the eye, that had not been there a week before she started; the streaks were still present at a four-month follow-up, and the skin changes remained after she stopped the drug. She carried one likely disease-causing variant in the gene behind the inherited form, and the authors judge it “highly likely” that abaloparatide set off the disease in her (Amjad et al., 2025). It is one case.
• What has not been tested — No human data in pregnancy and no animal reproduction studies; it is not indicated for women who can become pregnant and is not approved for children (Tymlos label). No drug-interaction studies have been done (Tymlos label); the EU label notes that vasoactive drugs may add to its blood-pressure-lowering effect and urges caution with digitalis (Eladynos EU label). Its safety beyond 2 years of treatment has not been studied (Tymlos label).
• Overdose — One trial patient received 400 µg in a day, five times the dose, and had weakness, headache, nausea and vertigo (Tymlos label).
• WADA — Abaloparatide is not named on the 2026 Prohibited List, and no section names parathyroid hormone, PTHrP or their analogs. Section S0 covers only substances “with no current approval by any governmental regulatory health authority for human therapeutic use”; abaloparatide has been FDA-approved since 2017, so S0 does not apply (World Anti-Doping Agency, 2026).

Bloodwork & Monitoring

What the labels list, and what the trials measured:

• Blood calcium — The US label warns against its use in people with high blood calcium or a disorder that raises it, such as primary hyperparathyroidism (Tymlos label). The EU label says calcium peaks about 4 hours after a dose and returns to baseline by 24 hours, that calcium samples, if taken, are drawn about 24 hours after the last injection, and that routine calcium monitoring is not required without other risk factors (Eladynos EU label).
• Urine calcium — Both labels describe measuring urinary calcium when kidney stones or high urine calcium are suspected (Tymlos label; Eladynos EU label).
• Heart — The EU label lists blood pressure, cardiac status and an ECG before treatment, and monitoring of people with heart disease (Eladynos EU label).
• Kidney function — Exposure is higher in severe kidney impairment, and the US label describes watching such patients for adverse reactions (Tymlos label); the EU label rules it out in severe kidney impairment (Eladynos EU label).
• In the osteoporosis trials — Spine X-rays for new fractures, bone density by DXA, and the turnover markers PINP and CTX (Miller et al., 2016; Tymlos label), serum calcium 4 hours after a dose, uric acid, antibodies, and blood pressure and heart rate after injection (Tymlos label; Cosman et al., 2020).
• In the healing trial — CT of the fracture at 3 months for cortical bridging, a numeric pain score, walking-speed, chair-stand and balance tests, and blood calcium, PINP and CTX at each visit (Nieves et al., 2026).
• Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.

Commonly Stacked With

Abaloparatide has been studied with calcium and vitamin D, before alendronate, and, in rats, with zoledronate (Kataoka et al., 2024); a trial adding it to denosumab has no results yet (NCT04467983), and a completed pilot that gave it with bevacizumab, given into a vein, to 20 people with myelodysplastic syndromes, a bone-marrow disorder, has posted no results, and no paper on it turned up in PubMed (NCT03746041; searched October 5, 2026). It has been compared with teriparatide, not combined with it, and no study has tested it with BPC-157, TB-500 or any other compound on this site (PubMed and Europe PMC, searched October 4, 2026).

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Legal Status

Related Compounds

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References

1. Radius Health, Inc. TYMLOS (abaloparatide) injection, for subcutaneous use. Prescribing information (initial U.S. approval 2017; Warnings and Precautions, Hypersensitivity Reactions, 08/2026). DailyMed set ID 712143d9-e21e-4013-bb3b-3426a21060a8, version 19, effective August 11, 2026. dailymed.nlm.nih.gov. Read October 4, 2026.
2. Radius Health, Inc. TYMLOS (abaloparatide) injection prescribing information, revised 04/2017, with the boxed warning “Risk of osteosarcoma.” accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf. Read October 4, 2026.
3. Radius Health, Inc. TYMLOS (abaloparatide) injection prescribing information, revised 12/2021 (supplement S-010): “Osteosarcoma Boxed Warning, Removed 12/2021.” accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf. Read October 4, 2026.
4. U.S. Food and Drug Administration. Drugs@FDA: NDA 208743, TYMLOS (abaloparatide) injection, 3.12 mg/1.56 mL, Radius; original approval April 28, 2017; prescription; supplements through August 3, 2026. api.fda.gov/drug/drugsfda.json. Read October 4, 2026.
5. U.S. Food and Drug Administration (FDA). Supplement approval letter, NDA 208743/S-013, December 19, 2022: new indication to increase bone density in men with osteoporosis at high risk for fracture. accessdata.fda.gov/drugsatfda_docs/appletter/2022/208743Orig1s013ltr.pdf. Read October 4, 2026.
6. European Medicines Agency (EMA). Eladynos (abaloparatide), EMEA/H/C/004157, applicant Radius International Ltd: refusal of the marketing authorisation. CHMP negative opinion 22 March 2018, confirmed on re-examination 26 July 2018; questions and answers EMA/504599/2018. ema.europa.eu/en/medicines/human/EPAR/eladynos-0. Read October 4, 2026.
7. European Medicines Agency (EMA). Eladynos (abaloparatide), EMEA/H/C/005928: EPAR overview; marketing authorisation holder Theramex Ireland Limited; authorised 12 December 2022. ema.europa.eu/en/medicines/human/EPAR/eladynos; EMA medicines data table (medicines-output-medicines_json-report). Read October 4, 2026.
8. Theramex Ireland Limited. Eladynos 80 micrograms/dose solution for injection in pre-filled pen: summary of product characteristics, the EU label (EU/1/22/1706; date of first authorisation 12 December 2022). ema.europa.eu/en/documents/product-information/eladynos-epar-product-information_en.pdf. Read October 4, 2026.
9. PMDA (Pharmaceuticals and Medical Devices Agency, Japan). List of Approved Products, New Drugs: April 2004 to February 2026 (“List of Approved Drugs”), entry of March 23, 2021: Ostabalo Subcutaneous Injection Cart 3 mg (Teijin Pharma Limited), abaloparatide acetate, a drug with a new active ingredient indicated for the treatment of osteoporosis with a high risk of fracture. pmda.go.jp/files/000281190.pdf. Read October 5, 2026.
10. Davenport C, Gravel P, Wang Y, Williams SA, Wieland A, Mitlak B. Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe. Ther Innov Regul Sci. 2024;58(3):505-518. PMID: 38341388. DOI: 10.1007/s43441-024-00616-7. (Full text at PMC11043175, read October 4, 2026: the EU history, the two excluded sites and Great Britain’s approval of Eladynos on 27 March 2023.)
11. National Library of Medicine. PubChem: Abaloparatide, CID 76943386 (C174H300N56O49, 3961 g/mol; synonyms include Tymlos, BA058 and BIM-44058). pubchem.ncbi.nlm.nih.gov. Read October 4, 2026.
12. Hattersley G, Dean T, Corbin BA, Bahar H, Gardella TJ. Binding Selectivity of Abaloparatide for PTH-Type-1-Receptor Conformations and Effects on Downstream Signaling. Endocrinology. 2016;157(1):141-149. PMID: 26562265. DOI: 10.1210/en.2015-1726.
13. Sato T, Verma S, Khatri A, Dean T, Goransson O, Gardella TJ, Wein MN. Comparable Initial Engagement of Intracellular Signaling Pathways by Parathyroid Hormone Receptor Ligands Teriparatide, Abaloparatide, and Long-Acting PTH. JBMR Plus. 2021;5(5):e10441. PMID: 33977197. DOI: 10.1002/jbm4.10441.
14. Zhai X, Mao C, Shen Q, Zang S, et al. Molecular insights into the distinct signaling duration for the peptide-induced PTH1R activation. Nat Commun. 2022;13(1):6276. PMID: 36271004. DOI: 10.1038/s41467-022-34009-x.
15. Makino A, Takagi H, Takahashi Y, Hase N, et al. Abaloparatide Exerts Bone Anabolic Effects with Less Stimulation of Bone Resorption-Related Factors: A Comparison with Teriparatide. Calcif Tissue Int. 2018;103(3):289-297. PMID: 29725706. DOI: 10.1007/s00223-018-0422-4.
16. Varela A, Chouinard L, Lesage E, Guldberg R, et al. One year of abaloparatide, a selective peptide activator of the PTH1 receptor, increased bone mass and strength in ovariectomized rats. Bone. 2017;95:143-150. PMID: 27894941. DOI: 10.1016/j.bone.2016.11.027.
17. Doyle N, Varela A, Haile S, Guldberg R, et al. Abaloparatide, a novel PTH receptor agonist, increased bone mass and strength in ovariectomized cynomolgus monkeys by increasing bone formation without increasing bone resorption. Osteoporos Int. 2018;29(3):685-697. PMID: 29260289. DOI: 10.1007/s00198-017-4323-6.
18. Jolette J, Attalla B, Varela A, Long GG, et al. Comparing the incidence of bone tumors in rats chronically exposed to the selective PTH type 1 receptor agonist abaloparatide or PTH(1-34). Regul Toxicol Pharmacol. 2017;86:356-365. PMID: 28389324. DOI: 10.1016/j.yrtph.2017.04.001.
19. Lanske B, Chandler H, Pierce A, Brown J, et al. Abaloparatide, a PTH receptor agonist with homology to PTHrP, enhances callus bridging and biomechanical properties in rats with femoral fracture. J Orthop Res. 2019;37(4):812-820. PMID: 30790359. DOI: 10.1002/jor.24254.
20. Bernhardsson M, Aspenberg P. Abaloparatide versus teriparatide: a head to head comparison of effects on fracture healing in mouse models. Acta Orthop. 2018;89(6):674-677. PMID: 30334479. DOI: 10.1080/17453674.2018.1523771.
21. Kataoka T, Tsubouchi Y, Takase R, Otsu T, et al. Preoperative abaloparatide plus zoledronate treatment accelerates femoral bone healing in rats following osteotomy. J Orthop Surg (Hong Kong). 2024;32(3):10225536241293486. PMID: 39403996. DOI: 10.1177/10225536241293486.
22. Makino A, Hasegawa T, Yamamoto T, Takagi H, et al. Abaloparatide promotes bone repair of vertebral defects in ovariectomized rats by increasing bone formation. Bone. 2024;182:117056. PMID: 38402920. DOI: 10.1016/j.bone.2024.117056.
23. Arlt H, Besschetnova T, Ominsky MS, Fredericks DC, Lanske B. Effects of systemically administered abaloparatide, an osteoanabolic PTHrP analog, as an adjuvant therapy for spinal fusion in rats. JOR Spine. 2021;4(1):e1132. PMID: 33778406. DOI: 10.1002/jsp2.1132.
24. Morse KW, Moore H, Kumagai H, Hahn W, et al. Abaloparatide Enhances Fusion and Bone Formation in a Rabbit Spinal Arthrodesis Model. Spine (Phila Pa 1976). 2022;47(22):1607-1612. PMID: 35943233. DOI: 10.1097/BRS.0000000000004452.
25. Xu J, Ye Z, Chen C, Zhang X, et al. Abaloparatide Improves Rotator Cuff Healing via Anabolic Effects on Bone Remodeling in a Chronic Rotator Cuff Tear Model of Rat With Osteoporosis: A Comparison With Denosumab. Am J Sports Med. 2022;50(6):1550-1563. PMID: 35404150. DOI: 10.1177/03635465221079651.
26. Eastman K, Gerlach M, Piec I, Greeves J, Fraser W. Effectiveness of parathyroid hormone (PTH) analogues on fracture healing: a meta-analysis. Osteoporos Int. 2021;32(8):1531-1546. PMID: 33559713. DOI: 10.1007/s00198-021-05847-0.
27. Leder BZ, O’Dea LS, Zanchetta JR, Kumar P, et al. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015;100(2):697-706. PMID: 25393645. DOI: 10.1210/jc.2014-3718.
28. Miller PD, Hattersley G, Riis BJ, Williams GC, et al. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016;316(7):722-733. PMID: 27533157. DOI: 10.1001/jama.2016.11136. (Erratum, “Incorrect Figures”: JAMA. 2017;317(4):442.)
29. Moreira CA, Fitzpatrick LA, Wang Y, Recker RR. Effects of abaloparatide-SC (BA058) on bone histology and histomorphometry: The ACTIVE phase 3 trial. Bone. 2017;97:314-319. PMID: 27826127. DOI: 10.1016/j.bone.2016.11.004.
30. Cosman F, Miller PD, Williams GC, Hattersley G, et al. Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clin Proc. 2017;92(2):200-210. PMID: 28160873. DOI: 10.1016/j.mayocp.2016.10.009.
31. Bone HG, Cosman F, Miller PD, Williams GC, et al. ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis. J Clin Endocrinol Metab. 2018;103(8):2949-2957. PMID: 29800372. DOI: 10.1210/jc.2018-00163.
32. Cosman F, Peterson LR, Towler DA, Mitlak B, Wang Y, Cummings SR. Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial. J Clin Endocrinol Metab. 2020;105(11):3384-3395. PMID: 32658264. DOI: 10.1210/clinem/dgaa450.
33. Czerwinski E, Cardona J, Plebanski R, Recknor C, et al. The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial. J Bone Miner Res. 2022;37(12):2435-2442. PMID: 36190391. DOI: 10.1002/jbmr.4719.
34. Matsumoto T, Sone T, Soen S, Tanaka S, Yamashita A, Inoue T. Abaloparatide Increases Lumbar Spine and Hip BMD in Japanese Patients With Osteoporosis: The Phase 3 ACTIVE-J Study. J Clin Endocrinol Metab. 2022;107(10):e4222-e4231. PMID: 35977548. DOI: 10.1210/clinem/dgac486.
35. Lewiecki EM, Czerwinski E, Recknor C, Strzelecka A, et al. Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study. J Bone Miner Res. 2023;38(10):1404-1414. PMID: 37417725. DOI: 10.1002/jbmr.4877.
36. Nieves JW, Cosman F, McMahon D, Berman H, et al. Abaloparatide and pelvic fracture healing: a phase 2 randomized placebo-controlled trial. Osteoporos Int. 2026 (published online). PMID: 42618812. DOI: 10.1007/s00198-026-08176-2. (Open-access full text read October 4, 2026.)
37. Nieves JW, Cosman F, McMahon D, Redko M, et al. Teriparatide and pelvic fracture healing: a phase 2 randomized controlled trial. Osteoporos Int. 2022;33(1):239-250. PMID: 34383100. DOI: 10.1007/s00198-021-06065-4.
38. Nickel B, Krueger D, Borchardt G, Mosiman S, Anderson PA, Binkley N. Abaloparatide Increases Distal Femur Bone Mineral Density Post-Total Knee Arthroplasty. JB JS Open Access. 2026;11(3). PMID: 42781663. DOI: 10.2106/JBJS.OA.26.00176.
39. VanDerwerker NB, Mosiman S, Krueger D, Binkley N, Anderson PA, Bernatz J. Three months of abaloparatide treatment rapidly improves bone formation and density: implications for orthopedic preoperative bone health optimization. Osteoporos Int. 2026 (published online). PMID: 42498818. DOI: 10.1007/s00198-026-08126-y.
40. Khalid SI, Wang R, Abou-Mrad T, Massaad E, et al. Association of Osteoporosis and Bone-Strengthening Medications with Postoperative Outcomes Following Transforaminal Lumbar Interbody Fusion. World Neurosurg. 2025;204:124553. PMID: 41072911. DOI: 10.1016/j.wneu.2025.124553.
41. Jain H, Sarikonda A, Ahluwalia R, Zakieh O, et al. A bone optimization rheumatology clinic increases anabolic bone agent use and reduces mechanical complications in adult spinal deformity surgery. Spine Deform. 2026;14(3):821-829. PMID: 41688596. DOI: 10.1007/s43390-026-01307-z.
42. Nelson JA, Gavin KJ. The use of abaloparatide to treat nonunion following dorsal closing wedge osteotomy for Freiberg’s disease: A case report. Bone Rep. 2021;15:101146. PMID: 34786439. DOI: 10.1016/j.bonr.2021.101146.
43. Nozaka K, Shirahata T, Yuasa Y, Harata S, Miyakoshi N. Biological activation of prolonged delayed fracture healing following abaloparatide under stable circular external fixation: successful limb salvage of a Gustilo type III-C pilon fracture in severe immune thrombocytopenia-a case report. J Med Case Rep. 2026;20(1). PMID: 42351259. DOI: 10.1186/s13256-026-06289-0.
44. Joko I, Uchida M, Hino M, Miyaoka S, et al. Rapid fracture healing of the greater tuberosity fragment after shoulder hemiarthroplasty in a patient with daily abaloparatide injection: A case report. Bone Rep. 2026;28:101899. PMID: 41626402. DOI: 10.1016/j.bonr.2026.101899.
45. Swanson CM, Krohn K, Wiseman A, Rothman MS. New Human Leukocyte Antigen (HLA) Antibody Formation and Creatinine Elevation With Abaloparatide in Kidney Transplant Recipient. JBMR Plus. 2023;7(12):e10814. PMID: 38130769. DOI: 10.1002/jbm4.10814.
46. Amjad SA, Pincelli T, Meek SE, Sokumbi O, Keeling J, Singer EM. Abaloparatide-induced pseudoxanthoma elasticum. JAAD Case Rep. 2025;61:133-135. PMID: 40606685. DOI: 10.1016/j.jdcr.2025.03.029.
47. ClinicalTrials.gov. Registrations of abaloparatide (BA058), API v2, read October 4–5, 2026: NCT00542425 (Phase 2, 222, results posted), NCT01343004 (ACTIVE, 2,463, results posted), NCT01657162 (ACTIVExtend, 1,139), NCT03512262 (ATOM, 228), NCT04064411 (patch, Phase 3, 511: 256 patch, 255 injection; 300 µg on the thigh for 5 minutes; sponsor Radius Health), NCT04249232 (pelvic fracture healing, Phase 2, 48, completed), NCT04760782 (odontoid fracture pilot, terminated for low recruitment, results posted: fracture union, median % bridging bone on CT at 3 months, 0 in the 1 treated participant measured and 3.6 (range 0–7.2) in the 2 controls measured), NCT03841058 (FAST-Healing, spinal fusion, Phase 2, active, not recruiting, primary completion estimated February 2027), NCT07587775 (lumbar fusion, Phase 2, enrolling by invitation), NCT04467983 (added to denosumab, Phase 4, active, not recruiting, primary completion estimated September 2026, no results posted), NCT06898060 (Qilu Pharmaceutical, Phase 3 against teriparatide, not yet recruiting), NCT06164795 (START, observational, sequential treatments in postmenopausal women, recruiting), NCT07616401 (ROMIRNA, blood markers of response, recruiting), NCT06753864 (bioequivalence against Tymlos, not yet recruiting, planned dates in 2025), NCT06154187 (Pharmbio Korea, Phase 3, placebo-controlled, status unknown), NCT03746041 (University of Rochester, Phase 1 pilot with bevacizumab in myelodysplastic syndromes, 20, completed, no results posted), NCT04626141 and NCT03708926 (withdrawn). clinicaltrials.gov.
48. A chemical supplier’s product information sheet for abaloparatide (acetate), copyright 2022: supplied as a solid, purity at least 95%, storage −20 °C, “for research only – not for human or veterinary diagnostic or therapeutic use.” Read October 4, 2026. The supplier is not named: Kalios doesn’t name or link vendors.
49. Code of Federal Regulations. 21 CFR 216.23 (bulk drug substances that can be used to compound under section 503A) and 216.24 (drug products withdrawn or removed from the market for reasons of safety or effectiveness). ecfr.gov. Read October 4, 2026.
50. 21 U.S.C. 353a, Pharmacy compounding (section 503A of the Federal Food, Drug, and Cosmetic Act), subsection (b)(1). law.cornell.edu/uscode/text/21/353a. Read October 5, 2026.
51. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated May 14, 2026. fda.gov/media/94155/download.
52. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated March 21, 2025. fda.gov/media/94164/download.
53. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S0, Non-approved substances; S2, Peptide hormones, growth factors, related substances and mimetics. wada-ama.org.
54. Searches of October 4, 2026: PubMed, “abaloparatide” (413 records), with “randomized controlled trial[pt]” (31), with fracture healing, nonunion or union (24), with spinal fusion terms (41), with tendon or rotator-cuff terms (3: one rat study, a letter about it and the authors’ reply), with “case reports[pt]” (10), with BPC-157, TB-500, GHK, growth-hormone secretagogues or testosterone (6 records, none testing a combination); Europe PMC, abaloparatide with on-site peptides (no study of a combination); ClinicalTrials.gov, “abaloparatide” (26 records); openFDA Drugs@FDA and labels, “abaloparatide” (one application, NDA 208743); EMA medicines data table, “abaloparatide” (two applications: refused 2018, authorised 2022); web search of fda.gov for warning letters naming abaloparatide (none found); web search for abaloparatide sold as research peptide (laboratory suppliers only, not named). Searches of October 5, 2026: PubMed, abaloparatide with myelodysplastic, bevacizumab or hematopoie* (0 records); ClinicalTrials.gov, “abaloparatide” (26 records, statuses re-read); PMDA’s list of approved new drugs, April 2004 to February 2026 (Ostabalo, March 23, 2021).

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