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Weight loss · Weekly shot

CagriSema

Gray market

Checked · 25 sources · 13 corrections on this page · No vendors · No affiliates · No one buys a word of it

−20.4% body weight

Phase III · 68 weeks · 2.4 mg of each drug once a week · REDEFINE 1 · Garvey 2025

Gray market · No FDA ruling — not on any list

Sold as a research chemical. Some clinics and pharmacies still supply it; that’s their risk, not a change in the rule.

Bottom line

Two published Phase 3 trials, and more weight lost than on semaglutide alone in the earlier trials (Enebo et al., 2021; Frias et al., 2023); FDA’s decision is the missing piece.

Also called
  • Cagrilintide + Semaglutide
  • Novo Nordisk fixed-dose combo
  • NN9838 + semaglutide
  • REDEFINE pipeline
Category
Combination Therapy — Amylin Analog + GLP-1 Agonist
Class
Amylin + GLP-1 combination
Components
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
Route (studied)
SubQ (people)
Route (sold)
Trials only; components as SubQ vials (research chemical)
Phase 3 REDEFINE 1
−20.4% @ 68 wk (non-DM)
Phase 3 REDEFINE 2
−13.7% @ 68 wk (T2D)
FDA Status
Under review
Pipeline
  • FDA decision expected in Q4 2026 (Novo Nordisk, September 21, 2026)
  • REDEFINE 3 cardiovascular outcomes trial (NCT05669755), primary completion est. Sep 2027
  • Phase 3, three ways of switching from semaglutide to CagriSema in type 2 diabetes (210 planned; recruiting) (NCT07817251), primary completion est. Jun 2027
Developer
Novo Nordisk
Trials
REDEFINE 1/2 complete; CVOT ongoing
WADA Status
Not specifically listed — prohibited at all times under S0 (no government has approved it for human use)
Cost & Access
Research-only (pending approval)

Also for weight loss

The other four questions

What does it do? It pairs semaglutide, which acts on the GLP-1 receptor (Lincoff et al., 2023), with cagrilintide, which acts on the amylin and calcitonin receptors (Fletcher et al., 2021). Together they took off more weight than semaglutide alone in the Phase 1b and Phase 2 trials (Enebo et al., 2021; Frias et al., 2023).
Who uses it? No one outside trials yet: it has been under FDA review since December 2025, with a decision expected in Q4 2026 (Novo Nordisk, September 21, 2026). Some people mix their own from separate cagrilintide and semaglutide vials bought from research-chemical sellers.
Does the evidence hold up? Yes, for weight: in Phase 3, 3,417 adults without diabetes lost 20.4% of body weight in 68 weeks, against 3.0% on placebo (Garvey et al., 2025), and 1,206 adults with type 2 diabetes lost 13.7%, against 3.4% (Davies et al., 2025).
Bottom line? Two published Phase 3 trials, and more weight lost than on semaglutide alone in the earlier trials (Enebo et al., 2021; Frias et al., 2023); FDA’s decision is the missing piece.

Dosing from the Literature

Published for fat loss: 2.4 mg of each drug once a week, reached step by step, from the REDEFINE trials. Not published: any trial of the lower doses mixed from separate vials.

The doses below are the ones given in the Phase 1b, 2 and 3 trials. CagriSema is not approved, so no labeled dose exists. This is research documentation, not medical advice.

ProtocolDoseFrequencyNotes
REDEFINE target doseCagrilintide 2.4 mg + semaglutide 2.4 mgOnce weekly SubQReached over 16 weeks, then 52 weeks at that dose (ClinicalTrials.gov NCT05567796). 2,108 adults without diabetes (REDEFINE 1; Garvey et al., 2025) and 904 with type 2 diabetes (REDEFINE 2; Davies et al., 2025), 68 weeks
Phase 1b (Enebo 2021)Cagrilintide 0.16–4.5 mg + semaglutide 2.4 mgOnce weekly SubQBoth raised every 4 weeks over 16 weeks, then 4 weeks at the target dose; 96 adults with overweight or obesity (Enebo et al., 2021)
Monotherapy comparatorSemaglutide 2.4 mg aloneOnce weekly SubQ302 adults in REDEFINE 1’s semaglutide-alone arm (Garvey et al., 2025)
DIY concurrent dosing (gray-market)Separate cagrilintide and semaglutide injectionsWeeklyWhat some users describe, ahead of approval, from research-chemical vials; no trial has tested it, and it is not the trial product
Dosing Disclaimer

CagriSema is investigational, with no approved dose anywhere, and research-chemical vials are unregulated for quality. In REDEFINE 1, gastrointestinal side effects affected 79.6% on the combination against 39.9% on placebo (Garvey et al., 2025). Consult a licensed clinician.

→ Calculator — vial-to-syringe math

What It Is

CagriSema is an investigational fixed-dose once-weekly subcutaneous combination anti-obesity drug developed by Novo Nordisk, pairing two peptides in a single injection: cagrilintide 2.4 mg (a long-acting lipidated analog of the pancreatic hormone amylin, code AM833 / NN9838) and semaglutide 2.4 mg (a GLP-1 receptor agonist already approved and marketed under the brand names Ozempic, Wegovy, and Rybelsus). The "CagriSema" portmanteau refers to this fixed-dose pairing — the two components are separately well-characterized peptides being jointly advanced for obesity as a single commercial product.

The rationale for combining the two is mechanistic. Native amylin and GLP-1 are both meal-related satiety hormones, but they act at different receptors expressed on different populations of CNS neurons. GLP-1 receptors are densely expressed in the hypothalamic (brain's hormonal control center) arcuate nucleus, the nucleus of the solitary tract (NTS), and the area postrema. Amylin receptors (calcitonin-receptor + RAMP complexes forming AMY1R, AMY2R, AMY3R) are most densely expressed in the area postrema and the NTS, with distinct downstream circuits. Because the two signaling systems converge on appetite regulation through substantially non-overlapping wiring, combining them offered the possibility of additive — not merely incremental — weight loss.

Phase 1b data (Enebo 2021) confirmed the hypothesis in short-term dosing. The REDEFINE Phase 3 program scaled the trial into pivotal non-diabetic obesity (REDEFINE 1) and obesity + type 2 diabetes (REDEFINE 2) populations. The headline REDEFINE 1 result — 20.4% mean weight loss at 68 weeks in 3,417 non-diabetic adults — was published in NEJM in June 2025 and places CagriSema roughly at parity with tirzepatide (SURMOUNT-1, −20.9%). REDEFINE 2 in T2D produced a smaller but still clinically meaningful 13.7% weight loss plus HbA1c improvement.

Novo Nordisk filed a New Drug Application for CagriSema in December 2025. As of September 28, 2026 it is under FDA review, with no decision yet; Novo expects one in Q4 2026. A cardiovascular outcomes trial (REDEFINE-CVOT) is underway but not required for the primary approval pathway. If approved, CagriSema would be the first fixed-dose amylin + GLP-1 combination product — the leading second-market-entry to the dual-agonist / combination obesity drug landscape established by tirzepatide. Its commercial positioning would target the upper-tier of obesity magnitude, competing directly with tirzepatide on weight loss and with retatrutide, Lilly's triple agonist.

Mechanism of Action

CagriSema is two drugs in one weekly regimen, each acting on its own receptors; the points below give what each does and what the trials found when the two were combined.

  • Semaglutide — GLP-1 receptor agonism — Semaglutide is a GLP-1 receptor agonist (Lincoff et al., 2023) that delays gastric emptying (Wegovy label).
  • Cagrilintide — amylin / calcitonin receptor agonism — Cagrilintide activates the amylin receptors, each the calcitonin receptor paired with a RAMP protein, and the calcitonin receptor itself, without selectivity (Fletcher et al., 2021; Hay et al., 2018). Natural amylin induces satiety (Lau et al., 2021).
  • Additive effect — Amylin-receptor drugs may act additively with GLP-1 drugs (Fletcher et al., 2021). In the Phase 1b trial, adding cagrilintide 2.4 mg to semaglutide took weight loss at 20 weeks from 9.8% to 17.1% (Enebo et al., 2021).
  • Glucose — In type 2 diabetes over 32 weeks, HbA1c fell 2.2 points on CagriSema, against 1.8 on semaglutide alone (not a significant difference) and 0.9 on cagrilintide alone (Frias et al., 2023); in REDEFINE 2, 73.5% reached an HbA1c of 6.5% or less, against 15.9% on placebo (Davies et al., 2025).
  • Shared once-weekly kinetics — Given together, cagrilintide did not change semaglutide’s exposure or elimination; their half-lives were 159–195 hours and 145–165 hours (Enebo et al., 2021).

What the Research Shows

CagriSema has one of the largest Phase 3 datasets of any obesity combination product, with two pivotal trials plus a cardiovascular outcomes trial underway.

  • Phase 1b proof-of-concept (Enebo Lancet 2021, PMID 33894838) — 96 randomized adults; cagrilintide (0.16–4.5 mg) + semaglutide 2.4 mg for 20 weeks. Weight loss: cagrilintide 1.2 mg + sema = −15.7%; cagrilintide 2.4 mg + sema = −17.1%; placebo + sema = −9.8%. Clinically confirmed additive effect.
  • Phase 2 CagriSema in T2D (Frias Lancet 2023) — 92 adults with T2D, 32 weeks. Weight fell 15.6% on cagrilintide 2.4 mg + semaglutide 2.4 mg, against 5.1% on semaglutide alone and 8.1% on cagrilintide alone; HbA1c fell 2.2 points, not significantly more than on semaglutide (1.8; p=0.075) (Frias et al., 2023).
  • REDEFINE 1 Phase 3 (Garvey et al., NEJM 2025) — 3,417 adults without diabetes, BMI ≥30 or ≥27 with weight-related comorbidity. 68 weeks. CagriSema: −20.4% weight loss vs −3.0% placebo. ~60% achieved ≥20% weight loss; ~23% achieved ≥30% weight loss. GI adverse events ~80% vs ~40%, mostly mild-moderate in titration phase.
  • REDEFINE 2 Phase 3 (Davies et al., NEJM 2025; PMID 40544432) — 1,206 adults with T2D + BMI ≥27 + HbA1c 7–10%. 68 weeks. CagriSema: −13.7% weight loss vs −3.4% placebo; HbA1c reduction confirmed.
  • REDEFINE-CVOT (ongoing) — Cardiovascular outcomes trial for longer-term safety and MACE endpoints; results pending.
  • Competitor benchmarks — Tirzepatide SURMOUNT-1 (−20.9% at 72 weeks non-DM), Semaglutide STEP-1 (−14.9% at 68 weeks non-DM), Retatrutide Phase 3 TRIUMPH-1 (−25.0% at 80 weeks; Jastreboff et al., 2026). CagriSema sits at tirzepatide-parity on magnitude in non-DM obesity, exceeding semaglutide alone and below retatrutide, across separate trials.
  • Amycretin successor program — Novo Nordisk's unimolecular GLP-1 + amylin single-peptide successor (Dahl et al., Lancet 2025; PMID 40550231) represents the strategic next step beyond CagriSema.
Honest Evidence Framing

CagriSema's Phase 3 program is well-powered and convincingly positive. The most important caveats are: (1) long-term safety beyond ~2 years remains to be demonstrated (REDEFINE-CVOT will address this); (2) GI adverse events were common, 79.6% against 39.9% on placebo in REDEFINE 1 (Garvey et al., 2025); (3) its head-to-head trial against tirzepatide in obesity completed in December 2025 (ClinicalTrials.gov NCT06131437), and no journal paper on it has appeared.

Human Data

CagriSema's human dataset is extensive and focused on the combination formulation specifically:

  • Phase 1 / 1b — PK/PD, tolerability, additivity proof-of-concept (Enebo 2021).
  • Phase 2 (T2D) — Frias Lancet 2023 active-controlled trial.
  • REDEFINE 1 — 3,417 non-diabetic adults; pivotal Phase 3 (NCT05567796).
  • REDEFINE 2 — 1,206 T2D adults; pivotal Phase 3 (NCT05394519; PMID 40544432).
  • REDEFINE 3 (NCT05669755) — The cardiovascular outcomes trial; active, primary completion expected September 2027 (ClinicalTrials.gov).
  • REDEFINE 1 and 2 together — 4,623 adults randomized for 68 weeks; in both, gastrointestinal events were the main adverse events, mostly transient and mild to moderate (Garvey et al., 2025; Davies et al., 2025).
  • Component track record — Both components are separately well-studied: semaglutide has multi-year Phase 3 / real-world data in over one million patients (STEP, SUSTAIN, SELECT, PIONEER, etc.); cagrilintide has completed Phase 2/3 as a solo and combination agent. The combination's safety inherits that track record.

Reconstitution & Storage

CagriSema has no approved label, so no official storage or handling instructions exist. Research-chemical sellers list the two components separately, as freeze-dried powder in vials. For a mixed vial, the arithmetic depends on the vial mass, the water volume and the dose; 2.4 mg is the trial dose of each (see Dosing).

ComponentVial / BACConcentration2.4 mg Dose Volume
Cagrilintide 5 mg2 mL BAC2.5 mg/mL0.96 mL (~96 units)
Cagrilintide 10 mg2 mL BAC5 mg/mL0.48 mL (~48 units)
Semaglutide 5 mg2 mL BAC2.5 mg/mL0.96 mL (~96 units)
Semaglutide 10 mg2 mL BAC5 mg/mL0.48 mL (~48 units)

→ Calculator — vial-to-syringe math

Side Effects & Risks

Important

CagriSema is investigational; the side effects below come from its trials and from the label of semaglutide, one of its two drugs. Consult a licensed healthcare provider.

In REDEFINE 1, gastrointestinal adverse events affected 79.6% on CagriSema against 39.9% on placebo, mainly transient and mild to moderate (Garvey et al., 2025); in REDEFINE 2, 72.5% against 34.4% (Davies et al., 2025).

  • Nausea, vomiting, diarrhea, constipation, abdominal pain — The gastrointestinal events counted in REDEFINE 1’s 79.6% (Garvey et al., 2025).
  • Injection site reactions — On cagrilintide alone in Phase 2, administration-site reactions were among the most frequent adverse events (Lau et al., 2021).
  • Gallbladder disease — Acute gallbladder disease is a listed warning on the label of semaglutide (Wegovy), one of CagriSema’s two drugs (Wegovy label).
  • Pancreatitis — Acute pancreatitis is a listed warning on the Wegovy label (Wegovy label).
  • Hypoglycemia risk — No level 2 or 3 hypoglycemia occurred in the 32-week Phase 2 trial in type 2 diabetes (Frias et al., 2023). The Wegovy label lists a higher risk of hypoglycemia when semaglutide is used with insulin or an insulin secretagogue (Wegovy label).
  • Heart rate increase — A listed warning on the Wegovy label (Wegovy label).
  • Thyroid C-cell / medullary thyroid boxed warning — Semaglutide carries a boxed warning: it caused thyroid C-cell tumors in rodents, whether it does in people is unknown, and a personal or family history of medullary thyroid carcinoma or MEN 2 is a contraindication (Wegovy label).
  • Diabetic retinopathy — Complications of diabetic retinopathy in people with type 2 diabetes are a listed warning on the Wegovy label (Wegovy label).
  • Pregnancy / lactation — No published data for CagriSema. The Wegovy label says to stop semaglutide at least 2 months before a planned pregnancy, because of its long half-life (Wegovy label).
  • Drug interactions — Semaglutide delays gastric emptying, which the Wegovy label says may affect the absorption of oral medicines, notably those with a narrow therapeutic index; the label also lists a higher risk of hypoglycemia with insulin or insulin secretagogues (Wegovy label).
  • WADA status — Not named on the Prohibited List, but prohibited at all times under S0, non-approved substances, because no government has approved it for human therapeutic use (WADA Prohibited List 2026).

Quick Compare — CagriSema vs Tirzepatide vs Semaglutide vs Retatrutide

CagriSema enters a competitive late-stage obesity-drug landscape with several near-term and mid-term rivals. The key comparators are tirzepatide (approved dual GIP/GLP-1), semaglutide (approved GLP-1, one of the components of CagriSema), and retatrutide (investigational triple GIP/GLP-1/glucagon agonist).

FeatureCagriSemaTirzepatideSemaglutideRetatrutide
ClassAmylin + GLP-1GIP + GLP-1GLP-1GIP + GLP-1 + glucagon
Route / cadenceSubQ weeklySubQ weeklySubQ weekly / oral dailySubQ weekly
Pivotal weight loss (non-DM)−20.4% @ 68 wk (REDEFINE 1)−20.9% @ 72 wk (SURMOUNT-1)−14.9% @ 68 wk (STEP-1)−25.0% @ 80 wk (TRIUMPH-1; Jastreboff et al., 2026)
Pivotal weight loss (T2D)−13.7% @ 68 wk (REDEFINE 2)SURPASS dataSUSTAIN data−18.8% @ 80 wk (TRIUMPH-2; Bellido et al., 2026)
Approval statusUnder FDA reviewApproved (Zepbound / Mounjaro)Approved (Wegovy / Ozempic / Rybelsus)Not approved; BLA planned Q1 2027 (Eli Lilly, July 23, 2026)
CV outcomesREDEFINE-CVOT ongoingSURPASS-CVOT: noninferior to dulaglutide (Nicholls et al., 2025; PMID 41406444)SELECT positive (20% MACE reduction)TRIUMPH-Outcomes (NCT06383390), due 2029
Oral optionNone expectedNoneRybelsus (oral semaglutide)None currently
Once-monthly optionNoneNoneNone approvedNone

Practical interpretation:

  • CagriSema vs tirzepatide — Approximately equal weight-loss magnitude in non-diabetic obesity (20.4% vs 20.9%). Different receptor mechanisms; choice may come down to tolerability, formulary, and clinician familiarity. Tirzepatide is approved now; CagriSema is pending.
  • CagriSema vs semaglutide — Weight fell more on CagriSema than on semaglutide alone in the Phase 1b and Phase 2 trials (Enebo et al., 2021; Frias et al., 2023); CagriSema is still investigational.
  • CagriSema vs retatrutide — Retatrutide's published Phase 3 obesity result, 25.0% weight loss at 80 weeks on 12 mg in TRIUMPH-1 (Jastreboff et al., 2026), is larger than CagriSema's 20.4% at 68 weeks in REDEFINE 1, but the trials differ in length and population, and no trial has compared the two.
  • Commercial positioning — Novo Nordisk and Eli Lilly dominate the obesity-drug landscape; CagriSema keeps Novo competitive with Lilly's tirzepatide and forthcoming retatrutide. The amycretin unimolecular successor is Novo's next step.

→ See Cagrilintide profile  •  → See Semaglutide profile  •  → See Tirzepatide profile  •  → See Retatrutide profile

Bloodwork & Monitoring

No label or guideline sets monitoring for CagriSema, which is investigational. Its trials measured body weight, HbA1c, fasting glucose and, in two, continuous glucose monitoring (Frias et al., 2023; Davies et al., 2025), and recorded adverse events (Garvey et al., 2025).

Commonly Stacked With

Cagrilintide  +  Semaglutide

The two drugs CagriSema is made of.

Tested together in people: Phase 1 to Phase 3 trials (CagriSema) (Garvey et al., 2025; Davies et al., 2025; Frias et al., 2023) · Read the receipt →

Tesamorelin

Tested together in people: none published · Read the receipt →

CJC-1295 + Ipamorelin

Tested together in people: none published · Read the receipt →

Stacking this? Read the receipt →

→ Calculator — vial-to-syringe math

Legal Status

Current Status — April 2026

CagriSema is under FDA review following Phase 3 readouts from REDEFINE 1 (non-diabetic obesity, NCT05567796) and REDEFINE 2 (obesity + T2D, NCT05394519), published simultaneously in the New England Journal of Medicine in June 2025. Novo Nordisk filed the New Drug Application in December 2025 and expects an FDA decision in Q4 2026 (Novo Nordisk, September 21, 2026).

CagriSema is not on the FDA Category 2 Bulk Drug Substances list. Semaglutide, in the form in Wegovy, is already a component of FDA-approved drugs (Wegovy label), and once CagriSema is approved, cagrilintide, in the form in CagriSema, will be one too; section 503A lets a licensed pharmacy compound with such a substance for a patient’s prescription, though not regularly or in inordinate amounts what is essentially a copy of a commercially available drug, CagriSema included (FDA 503A page, read October 18, 2026; 21 U.S.C. 353a). An outsourcing facility can compound from a bulk substance only if it is on the 503B bulks list or the drug made from it is on FDA’s drug shortage list (FDA 503B page, read October 18, 2026).

CagriSema is not named on the WADA Prohibited List, but it is prohibited at all times under S0, non-approved substances, because no government has approved it for human therapeutic use (WADA Prohibited List 2026).

Semaglutide (component) is FDA-approved; cagrilintide (component) is investigational. The fixed-dose combination is not yet approved in any market as of April 2026.

Cost & Access

CagriSema is not approved for human use. It is available only as a pairing of research-grade cagrilintide + research-grade or compounded semaglutide, purchased separately from research suppliers for laboratory research purposes. No U.S. compounding pharmacy can legally compound cagrilintide — it has no FDA-approved reference product.

What some users describe is mixing separate cagrilintide and semaglutide vials and injecting them as two shots, or one combined draw, on the same day. This is not the trial product, and the dose depends on each vial’s actual potency.

CagriSema was not among the 12 peptides FDA removed from Category 2 in April 2026 (FDA 503A categories list, April 22, 2026). Its regulatory pathway is standard FDA approval, not compounding reclassification.

Access and availability information as of April 2026. Kalios does not sell compounds.

References

  1. Garvey WT, Blüher M, Osorto Contreras CK, Davies MJ, Winning Lehmann E, Pietiläinen KH, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1). N Engl J Med. 2025;393(7):635-647. PMID: 40544433. DOI: 10.1056/NEJMoa2502081.
  2. Davies MJ, Bajaj HS, Broholm C, Eliasen A, Garvey WT, le Roux CW, et al. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2). N Engl J Med. 2025;393(7):648-659. PMID: 40544432. DOI: 10.1056/NEJMoa2502082.
  3. Enebo LB, Berthelsen KK, Kankam M, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021;397(10286):1736-1748. PMID: 33894838.
  4. Frias JP, Deenadayalan S, Erichsen L, et al. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2023;402(10403):720-730. PMID: 37364590.
  5. Lau DCW, Erichsen L, Francisco AM, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021;398(10317):2160-2172. PMID: 34798060.
  6. Fletcher MM, Keov P, Truong TT, et al. AM833 Is a Novel Agonist of Calcitonin Family G Protein-Coupled Receptors: Pharmacological Comparison with Six Selective and Nonselective Agonists. J Pharmacol Exp Ther. 2021;377(3):417-440. PMID: 33727283.
  7. Kruse T, Hansen JL, Dahl K, et al. Development of Cagrilintide, a Long-Acting Amylin Analogue. J Med Chem. 2021;64(15):11183-11194. PMID: 34288673.
  8. Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP-1). N Engl J Med. 2021;384(11):989-1002. PMID: 33567185. (Semaglutide-alone comparator.)
  9. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). N Engl J Med. 2022;387(3):205-216. PMID: 35658024. (Competing dual-agonist.)
  10. Jastreboff AM, Kaplan LM, Frías JP, et al. Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. N Engl J Med. 2023;389(6):514-526. PMID: 37366315. (Competing triple-agonist.)
  11. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT). N Engl J Med. 2023;389(24):2221-2232. PMID: 37952131. (Semaglutide CV benchmark.)
  12. Hay DL, Garelja ML, Poyner DR, Walker CS. Update on the pharmacology of calcitonin/CGRP family of peptides: IUPHAR Review 25. Br J Pharmacol. 2018;175(1):3-17. PMID: 29059473.
  13. Novo Nordisk. REDEFINE 1 press release and investor presentation, June 2025.
  14. ClinicalTrials.gov. REDEFINE 1: NCT05567796. REDEFINE 2: NCT05394519. REDEFINE-CVOT: Novo Nordisk cardiovascular outcomes trial.
  15. Dahl K, Toubro S, Dey S, Duque do Vale R, Flint A, Gasiorek A, Heydorn A, Jastreboff AM, et al. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. Lancet. 2025;406(10499):149-162. PMID: 40550231. (Successor single-molecule program.)
  16. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (503A categories list), versions updated April 15, April 22 and May 14, 2026. fda.gov/media/94155/download. Read October 3, 2026. (Notice that 12 peptides would leave Category 2 because their nominations were withdrawn; their removal; GHK-Cu, except injectable, back in Category 1.)
  17. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S0, Non-approved substances. wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf. Read October 3, 2026.
  18. Novo Nordisk. Wegovy (semaglutide) injection and tablets, prescribing information. DailyMed set ID ee06186f-2aa3-4990-a760-757579d8f77b (version 19, revised June 2026). dailymed.nlm.nih.gov. Read October 4, 2026.
  19. Jastreboff AM, Kaplan LM, Davies MJ, et al. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity (TRIUMPH-1). N Engl J Med. 2026 (published online September 29, 2026). PMID: 42814954. DOI: 10.1056/NEJMoa2604169.
  20. Bellido V, le Roux CW, Ekinci EI, et al. Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 (published online September 29, 2026). PMID: 42810372. DOI: 10.1016/S0140-6736(26)01861-1.
  21. Eli Lilly and Company. Lilly’s triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C. Press release, July 23, 2026 (PR Newswire). prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-successful-in-two-additional-phase-3-obesity-trials-delivering-significant-improvements-in-weight-and-a1c-302832674.html. Read October 4, 2026.
  22. Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D; SURPASS-CVOT Investigators. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med. 2025;393(24):2409-2420. PMID: 41406444.
  23. FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (503A page). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act. Read October 18, 2026.
  24. 21 U.S.C. 353a, Pharmacy compounding (section 503A of the Federal Food, Drug, and Cosmetic Act), United States Code, 2024 edition. https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapV-partA-sec353a.htm. Read October 18, 2026.
  25. FDA. Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act (503B page). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503b-fdc-act. Read October 18, 2026.

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Checked 18 Oct 2026