# Cagrilintide: FDA Status, Research and Uses

> Cagrilintide FDA status (not approved), why FDA says it cannot be compounded, CagriSema and REDEFINE trial results, and reported side effects.

- Canonical URL: https://livingpluspeptides.com/peptides/cagrilintide/
- Last updated: October 25, 2026
- Publisher: Living+

Cagrilintide is an experimental long-acting amylin analog. It is not part of any FDA-approved drug, and FDA says it cannot be used in compounding. It has been studied alone and with semaglutide, a mix called CagriSema, for weight loss and type 2 diabetes in phase 2 and phase 3 trials [1, 6, 7, 8].

## Regulatory status

- FDA approved: No
- 503A compounding: [Not nominated](https://www.fda.gov/media/94155/download). Not listed in any 503A nomination category (list updated May 14, 2026). FDA states cagrilintide cannot be used in compounding under federal law and is not a component of an FDA-approved drug (page current Oct 1, 2026).
- 503B bulks list: [Not nominated](https://www.fda.gov/media/94164/download). Not listed in FDA's 503B nomination categories (updated Mar 21, 2025). FDA says it cannot be used in compounding under federal law.
- WADA prohibited: [Unclear](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (Not named on the 2026 or 2027 List. S0 (non-approved substances) may apply, since it covers substances no government has approved for human use. The 2027 List, in force January 1, 2027, adds peptides as an S0 example.)
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22cagrilintide%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [FDA: Concerns with unapproved GLP-1 drugs used for weight loss](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss), [FDA: Bulk drug substances nominated under section 503A (updated May 14, 2026)](https://www.fda.gov/media/94155/download), [FDA: Bulk drug substances nominated under section 503B (updated Mar 21, 2025)](https://www.fda.gov/media/94164/download), [FDA: Warning letter, cagrilintide products (Dec 10, 2024)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA Drugs@FDA query: cagrilintide (no matches)](https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22cagrilintide%22), [openFDA drug shortages query: cagrilintide](https://api.fda.gov/drug/shortages.json?search=generic_name:%22cagrilintide%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Long-acting amylin analog (investigational) [1, 3]
- Amino-acid length: Lipidated amylin analog built on the pramlintide backbone (residue count not stated in cited sources) [3, 4]
- Half-life: About 159 to 195 hours (phase 1b study) [2]
- Route used in studies: Under the skin once weekly in studies [1]
- First studied: 2021 (first published human trial and chemistry reports) [2, 3]

## How it works

Amylin is a hormone made by the pancreas. It helps people feel full after eating [1]. Natural amylin is hard to use as a drug because it tends to clump into amyloid fibrils. An older amylin drug, pramlintide, needs three injections a day because it lasts only a short time [3].

Cagrilintide was designed to fix both problems. It is a stable amylin analog with a fatty acid (lipid) attached, which makes it last much longer [3]. Researchers built it on the pramlintide backbone and changed a few building blocks [4]. A phase 1b study found a half-life of about 159 to 195 hours, which supports once-weekly dosing [2].

Cagrilintide binds to calcitonin receptors and amylin receptors. A 2025 structural study mapped how it attaches to these receptors [4]. Researchers have also tested cagrilintide together with semaglutide, a GLP-1 drug [6].

Because cagrilintide is still experimental, its effects come only from research studies. In the phase 2 trial, all doses lowered body weight more than placebo [1]. FDA says cagrilintide has not been found safe and effective for any condition [8].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: REDEFINE 1 | 2025 | 3,417 adults with obesity or overweight, without diabetes | Phase 3a, randomized, double-blind, placebo and active controlled, 68 weeks; CagriSema, semaglutide alone, cagrilintide alone or placebo | Studied for weight loss: weight fell 20.4% with cagrilintide plus semaglutide vs 3.0% with placebo [6] | [Source](https://pubmed.ncbi.nlm.nih.gov/40544433/) |
| Human trial: REDEFINE 2 | 2025 | 1,206 adults with obesity or overweight and type 2 diabetes | Phase 3a, randomized, double-blind, placebo-controlled, 68 weeks, cagrilintide 2.4 mg plus semaglutide 2.4 mg weekly | Weight fell 13.7% vs 3.4% with placebo [7] | [Source](https://pubmed.ncbi.nlm.nih.gov/40544432/) |
| Human trial: Phase 2 trial in type 2 diabetes | 2023 | 92 adults with type 2 diabetes | Phase 2, randomized, double-blind, active controlled, 32 weeks; CagriSema vs semaglutide vs cagrilintide, each 2.4 mg | Weight fell 15.6% with CagriSema, 5.1% with semaglutide and 8.1% with cagrilintide [5] | [Source](https://pubmed.ncbi.nlm.nih.gov/37364590/) |
| Human trial: Phase 2 dose-finding trial | 2021 | 706 adults with obesity or overweight, without diabetes | Phase 2, randomized, double-blind, placebo and liraglutide controlled, 26 weeks, 0.3 to 4.5 mg weekly | Weight fell 6.0% to 10.8% vs 3.0% with placebo; 4.5 mg exceeded liraglutide 3.0 mg (10.8% vs 9.0%) [1] | [Source](https://pubmed.ncbi.nlm.nih.gov/34798060/) |
| Human trial: Phase 1b with semaglutide | 2021 | 96 adults with overweight or obesity, otherwise healthy | Phase 1b, randomized, placebo-controlled, multiple ascending dose, with semaglutide 2.4 mg | Half-life 159 to 195 hours; most side effects were mild to moderate [2] | [Source](https://pubmed.ncbi.nlm.nih.gov/33894838/) |
| Lab study: Development of cagrilintide | 2021 | Lab and animal studies | Medicinal chemistry and structure-activity studies | Selected as a stable, lipidated, long-acting amylin analog for clinical study [3] | [Source](https://pubmed.ncbi.nlm.nih.gov/34288673/) |

## Doses used in studies

The phase 2 trial gave 0.3, 0.6, 1.2, 2.4 or 4.5 mg once weekly for 26 weeks [1]. The phase 1b study tested 0.16 mg to 4.5 mg once weekly, each given with semaglutide 2.4 mg [2].

The phase 3 REDEFINE trials used cagrilintide 2.4 mg plus semaglutide 2.4 mg once weekly for 68 weeks, and REDEFINE 1 also had a cagrilintide 2.4 mg alone group [6, 7]. There is no FDA-approved dose, because cagrilintide is not part of an approved drug [8].

**Dosing is set by a licensed provider.**

## Side effects and safety

In the phase 2 trial, the most frequent side effects were stomach problems, such as nausea, constipation and diarrhea, and reactions at the injection site. Stomach side effects affected 41% to 63% on cagrilintide vs 32% on placebo, mostly nausea [1].

With cagrilintide plus semaglutide in REDEFINE 1, stomach side effects affected 79.6% vs 39.9% on placebo. They were mainly short-lived and mild to moderate [6]. In REDEFINE 2, the rate was 72.5% vs 34.4% [7].

FDA says cagrilintide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition [8]. FDA has sent a warning letter to an online seller of cagrilintide products labeled for research, calling them unapproved new drugs [12].

- [FDA: Concerns with unapproved GLP-1 drugs used for weight loss, including cagrilintide (page current as of Oct 1, 2026)](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) (2026-10-01)
- [FDA warning letter to an online seller of cagrilintide products](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024) (2024-12-10)

## Legal and regulatory status

- 2026-10-01: FDA's GLP-1 concerns page states that cagrilintide cannot be used in compounding under federal law and is not a component of any FDA-approved drug [8]. [Source](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
- 2026-05-14: Cagrilintide does not appear in any category of FDA's list of bulk substances nominated for 503A compounding (list updated May 14, 2026) [9]. [Source](https://www.fda.gov/media/94155/download)
- 2026-01-01: The WADA 2026 Prohibited List took effect. Its S0 class bans drugs in clinical development with no approval for human use. WADA does not name cagrilintide, so its status rests on that general wording [11]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2024-12-10: FDA issued a warning letter over cagrilintide and cagrilintide-semaglutide products sold online as research products, calling them unapproved new drugs [12]. [Source](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-cagrilintide).

## Frequently asked questions

### Is cagrilintide FDA approved?

No. FDA says cagrilintide is not a component of any FDA-approved drug and has not been found safe and effective for any condition [8].

### What is CagriSema?

CagriSema is the name used in trials for cagrilintide 2.4 mg given with semaglutide 2.4 mg once weekly [6, 7].

### Is CagriSema approved?

No. FDA's page, current as of October 1, 2026, says cagrilintide is not a component of any FDA-approved drug [8].

### Can cagrilintide be compounded?

No. FDA says cagrilintide cannot be used in compounding under federal law [8]. It does not appear on FDA's 503A or 503B nomination category lists [9, 10].

### How much weight loss was seen with cagrilintide?

In phase 2, cagrilintide alone lowered weight 6.0% to 10.8% over 26 weeks [1]. With semaglutide in REDEFINE 1, weight fell 20.4% over 68 weeks [6].

### How is cagrilintide different from semaglutide?

Semaglutide acts on the GLP-1 receptor. Cagrilintide is an amylin analog that acts on amylin and calcitonin receptors [4, 6].

### What side effects were reported with cagrilintide?

Nausea, constipation, diarrhea and injection-site reactions were most frequent in the phase 2 trial [1].

### Is cagrilintide banned in sports?

Unclear. WADA's S0 class bans substances with no approval for human use. WADA does not name cagrilintide, so this status is not explicit [11].

## Sources

1. [Lau et al. 2021, Lancet: Once-weekly cagrilintide phase 2 trial (PubMed)](https://pubmed.ncbi.nlm.nih.gov/34798060/)
2. [Enebo et al. 2021, Lancet: Cagrilintide with semaglutide phase 1b (PubMed)](https://pubmed.ncbi.nlm.nih.gov/33894838/)
3. [Kruse et al. 2021, J Med Chem: Development of cagrilintide (PubMed)](https://pubmed.ncbi.nlm.nih.gov/34288673/)
4. [Nature Communications 2025: Cagrilintide binding to calcitonin and amylin receptors (PMC)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11982234/)
5. [Frias et al. 2023, Lancet: CagriSema phase 2 in type 2 diabetes (PubMed)](https://pubmed.ncbi.nlm.nih.gov/37364590/)
6. [Garvey et al. 2025, NEJM: REDEFINE 1 (PubMed)](https://pubmed.ncbi.nlm.nih.gov/40544433/)
7. [Davies et al. 2025, NEJM: REDEFINE 2 (PubMed)](https://pubmed.ncbi.nlm.nih.gov/40544432/)
8. [FDA: Concerns with unapproved GLP-1 drugs used for weight loss](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
9. [FDA: Bulk drug substances nominated for use in compounding under section 503A (updated May 14, 2026)](https://www.fda.gov/media/94155/download)
10. [FDA: Bulk drug substances nominated for use in compounding under section 503B (updated Mar 21, 2025)](https://www.fda.gov/media/94164/download)
11. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
12. [FDA: Warning letter, cagrilintide products (Dec 10, 2024)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024)

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