CagriSema

Areas of active research — not promised effects

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CagriSema is not FDA-approved. Novo Nordisk filed an NDA with the FDA on December 18, 2025, for chronic weight management in adults with obesity. Under standard 10-month review, an FDA decision is anticipated approximately October 2026. The compound is not on the FDA 503A/503B Category 1 or Category 2 compounding lists. It is not subject to the 2026 FDA compounding motion affecting peptides (which applies to the FDA-503A list; this compound is not currently on that list). Extra-clinical procurement or use outside of approved clinical trials is not authorized.

Transparent blend · bci-1.0 · never paid-placement

Primary name

CagriSema

Origin

CagriSema is a co-formulated, fixed-dose investigational combination developed by Novo Nordisk, combining cagrilintide — a long-acting amylin analog engineered via fatty di-acid conjugation — with semaglutide, an established long-acting GLP-1 receptor agonist. Both components are synthetic peptide derivatives designed for once-weekly subcutaneous injection.

Sequence not available in current seed.

Vial sizes

null mg

Purity grades

Salt forms

Free base (primary)

• GHS hazard class on file
• PPE & spill response
• Disposal guidance
• Not-for-human-consumption posture

Long-acting amylin analogue in late-stage clinical development, studied as weekly subcutaneous co-therapy with semaglutide for obesity and type 2 diabetes.

Cagrilintide binds as a non-selective agonist at amylin receptors AMY1, AMY2, and AMY3 — heterodimeric complexes formed by the calcitonin receptor (CTR) paired with receptor activity-modifying proteins RAMP1, RAMP2, and RAMP3, respectively. Receptor engagement activates cAMP-dependent signalling cascades in the brainstem area postrema, suppressing appetite and reducing postprandial glucagon secretion. The compound also slows gastric emptying, contributing to reduced caloric intake, and displays binding kinetics at the CTR that differ from those of salmon calcitonin despite a broadly similar in-vitro pharmacological profile. The long-chain fatty-acid conjugation that confers the extended half-life does not alter the amylin-like binding mode at the receptor but induces distinct conformational dynamics relative to native amylin.

Molar mass

4409 g/mol

Long-acting GLP-1 receptor agonist approved for type 2 diabetes and obesity; once-weekly injection (Ozempic/Wegovy) or once-daily oral tablet (Rybelsus).

Semaglutide binds selectively and with high affinity to the GLP-1 receptor, a Gs-protein-coupled receptor expressed most densely in pancreatic beta cells, the hypothalamus, brainstem, myocardium, and gastrointestinal tract. Receptor activation elevates intracellular cyclic AMP via adenylyl cyclase, potentiating glucose-dependent insulin secretion from pancreatic beta cells while suppressing glucagon release from alpha cells — both effects diminish as blood glucose approaches euglycemia, substantially reducing hypoglycemia risk compared with sulfonylurea secretagogues. In the central nervous system, semaglutide activates hypothalamic and brainstem GLP-1 receptors (including arcuate nucleus POMC/CART neurons and area postrema neurons) to reduce appetite, increase satiety signaling, and modulate reward-related feeding behavior, collectively producing dose-dependent reductions in caloric intake that underlie the weight-loss efficacy observed at the higher doses used in Wegovy. Additionally, semaglutide slows gastric emptying, attenuating postprandial glucose excursions, and exerts direct cardioprotective effects through GLP-1 receptor signaling in cardiomyocytes and vascular endothelium, which are thought to contribute to the demonstrated reductions in major adverse cardiovascular events in the SUSTAIN-6 and SELECT outcome trials.

Molar mass

4114 g/mol

How much research exists, and of what maturity — never a verdict on whether it works.

Mechanism of action

• Semaglutide acts as a GLP-1 receptor agonist, reducing appetite through hypothalamic signaling, stimulating glucose-dependent insulin secretion, suppressing glucagon release, and slowing gastric emptying
• Cagrilintide activates amylin receptors (AMY1, AMY2, AMY3) — heteromeric complexes of the calcitonin receptor with receptor activity-modifying proteins — engaging brainstem and hypothalamic satiety pathways distinct from the GLP-1 axis
• The combination is designed to produce additive or synergistic appetite suppression by engaging complementary central and peripheral mechanisms simultaneously
• In the REDEFINE 1 Phase 3 trial, the combination achieved 22.7% mean body weight reduction at 68 weeks versus 16.0% for semaglutide monotherapy, consistent with additive activity across both receptor systems

Pharmacokinetics (ADME)

Half-life

Cagrilintide ~7.3 days; semaglutide >7 days — both support once-weekly dosing

Clearance

Not publicly reported in detail; both components are expected to undergo proteolytic clearance with renal contribution

PK–PD note: Cagrilintide's extended half-life is achieved through a C-20 fatty di-acid modification via an alpha-glutamyl spacer enabling albumin binding. The co-formulation maintains individual component PK prof…

Reading the evidence

• Evidence quality and gaps vary by application — see the cited grades above.
• Indexed-article counts span all evidence tiers, not only completed human trials.
• No first-party human-dosing, efficacy, or benefit claims are made here.

Key reviews & evidence-gap sources

• Dutta D, et al. Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (Cagrisema) as Anti-Obesity Medications: A Systematic Review and Meta-Analysis. Indian J Endocrinol Metab. 2024;28(5):436-444. — Anchoring systematic review/meta-analysis; PROSPERO CRD42023460291; analyzed 3 RCTs, 430 individuals
• CagriSema Versus Semaglutide Monotherapy or Placebo for Obesity: A Systematic Review and Meta-Analysis of RCTs with GRADE Assessment. Am J Clin Nutr. 2026. — Systematic review/meta-analysis, MEDLINE search to July 2025
• Ahmed et al. Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide: A Systematic Review, Meta-Analysis and Meta-Regression. Diabetes Obes Metab. 2026.

5 registered trials — 1 currently recruiting.

Phase 2
NCT06797869
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

ACTIVE_NOT_RECRUITING

Phase 1
NCT06207877
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight

COMPLETED

Phase 1
NCT07184086
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet

RECRUITING

Phase 3
NCT05394519
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

COMPLETED

Phase 3
NCT05567796
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

ACTIVE_NOT_RECRUITING

Summary (literature)

In the REDEFINE 1 Phase 3 trial, gastrointestinal adverse events were the predominant safety signal, occurring in approximately 79.6% of participants receiving CagriSema versus 39.9% on placebo. Nausea (approximately 55% vs 12.6%), constipation (approximately 30.7% vs 11.6%), and…

WADA status

Not specifically listed on the WADA Prohibited List by name as of 2026. Semaglutide and cagrilintide are not currently on the WADA Prohibited List. However, ath…

Dominant research route: Subcutaneous (SC) — once-weekly injection is the sole route studied across all Phase 1b–3 trials and the FDA filing.

Once-weekly subcutaneous injection of fixed-dose combination cagrilintide 2.4 mg + semaglutide 2.4 mg; studied in Phase 1b (PK/PD, ascending doses 0.16–4.5 mg cagrilintide + 2.4 mg semaglutide), Phase 2 (T2D, 32 weeks), and Phase 3 REDEFINE 1/2 (obesity and T2D, 68 weeks) in adults

Bioavailability: Cagrilintide half-life ~159–195 hours (~6.6–8.1 days); semaglutide half-life ~165 hours (~7 days); both suitable for once-weekly SC dosing. Phase 1b trial assessed pharmacokinetics of concomitant SC cagrilintide (multiple ascending doses) with SC semaglutide 2.4 mg.

All clinical development of CagriSema (Phase 1b through Phase 3 REDEFINE program) uses once-weekly subcutaneous administration. Novo Nordisk filed for FDA approval of CagriSema as a once-weekly SC formulation. No other route has been studied for the combination product.

Animal & human figures are kept visibly separate so studied animal doses are never misread as human guidance.

Sorted A–Z by vendor — never by price

Weekly median $/mg from the live vendor crawl.

Researched storefront prices, bucketed

What each test proves — general guidance, plus this compound's researched purity data

Independent labs cited for this compound

No recalls specific to CagriSema found. CagriSema is an investigational product not yet FDA-approved or commercially marketed; no CagriSema-branded product exists in the supply chain to recall. Counterfeit semaglutide (a CagriSema component) seizures have occurred repeatedly (2023, 2025) but pertain to Ozempic, not CagriSema.

Buyer red-flag checklist

• CagriSema is NOT FDA-approved; it is investigational. Any product sold as 'CagriSema' outside of clinical trials is unapproved and potentially counterfeit.
• Cagrilintide (a CagriSema component) cannot be used in compounding under federal law per FDA; any compounded product claiming to contain cagrilintide is illegal.
• Semaglutide (a CagriSema component) has been subject to repeated counterfeit seizures in the U.S. drug supply chain (2023, 2025).
• FDA Import Alert 66-80 subjects foreign-sourced GLP-1 APIs (including semaglutide) to detention without physical examination if not on the Green List.
• FDA has issued warning letters to multiple companies for selling unapproved semaglutide products online.
• FDA reports dosing errors with compounded semaglutide products, some requiring hospitalization.
• No independent third-party lab testing data specific to CagriSema was found in public databases.

GMP vs research-grade: the chemistry (SPPS + HPLC + MS) is identical — the difference is the quality system.

Underdosing / mislabeling: No independent lab test data (Janoshik, MZ Biolabs, Finnrick, etc.) specific to CagriSema was found. CagriSema is investigational and not commercially available as a standalone peptide product. FDA has reported dosing errors with compounded semaglutide (a CagriSema component) requiring hospitalization, and 21% of 48 foreign GLP-1 API sites evaluated by FDA were found noncompliant with CGMP, indicating quality risk in the broader GLP-1 API supply chain.

• Detention Without Physical Examination of GLP-1 Receptor Agonist Bulk Drug Substances. Covers semaglutide and other GLP-1 APIs from foreign manufacturers not on FDA's Green List. FDA found 21% of 48 evaluated GLP-1 API sites noncompliant with CGMP. Revised 06/22/2026.66-80
• An RUO label is not an import exemption — CBP judges actual intended use.
• Lyophilized powder is ambient-stable in transit; temperature control needed for > 7-day transit.
• US-warehouse vendors dodge import scrutiny — they cost more but ship more reliably.

Every item dated & sourced

Not prohibited. Semaglutide (a CagriSema component) is listed on WADA's Monitoring Program (added 2024, continued through 2025 and 2026) to track patterns of use in sport; it is not on the Prohibited List. CagriSema as a combination product is not individually listed.

No granted patents identified in current seed. Composition-of-matter coverage is limited given the peptide's synthetic origin.

• IACUC / IRB research context
• RUO buyer responsibilities & documentation
• Veterinary / alternative-use where lawful
• Jurisdiction-aware "who may lawfully obtain"

What people discuss

Reported concerns — discussion, not established effects

Reading caveats

• Trial-participant self-selection bias
• Blinded-trial placebo-group uncertainty in self-reports
• Enthusiasm / early-adopter positivity bias
• Investor sentiment conflated with patient experience
• Predominantly US-centric English-language discourse

Manually researched from reddit, youtube, x— theme weights are research estimates, not live counts; aggregated & de-identified. No individual posts, quotes, or usernames are ever shown.

Relative research / market volume — populated once the activity stream is wired

Inline tooltips for lyophilized, RUO, EU/mg, SPPS, 503A and more.

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• How to read a COA
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• Understanding evidence grades

Fixed-dose co-formulation of cagrilintide (amylin analog) and semaglutide (GLP-1 RA) under FDA review for chronic weight management; NDA filed December 2025. Approximately 53 articles are indexed (literature last scanned 2026-05-29). US regulatory status: Investigational — NDA under FDA review. Research use only.

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