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Not FDA approved
This peptide is not FDA approved for human use, and because peptides are often incompletely studied you should not use or self-experiment with it outside qualified medical supervision.
Overview
Cagrilintide is an investigational long-acting amylin version, also called AM833. Human clinical data exist, but the strongest late-stage efficacy headlines often cited publicly are for the fixed-dose CagriSema combination with semaglutide rather than for standalone cagrilintide.
Reviewed openFDA queries did not identify an FDA-approved cagrilintide or CagriSema product as of 2026-03-08.
Reported benefits
- Once-weekly subcutaneous dosing in human trials.
- Human evidence for appetite and weight effects in obesity studies.
- Studied in combination with semaglutide as CagriSema.
- Late-stage development program, but still investigational rather than FDA approved.
Mechanism of action
Cagrilintide is a long-acting amylin version that activates amylin receptor complexes built from the calcitonin receptor and receptor-activity-modifying proteins. Reviewed sources describe reduced food intake, delayed gastric emptying (how quickly food leaves the stomach), and metabolic effects consistent with amylin signaling.
Combination development with semaglutide aims to target distinct satiety (the feeling of fullness after eating) pathways, but that combination result should not be misread as proof of standalone cagrilintide efficacy at the same level.
Reported Use
No FDA dosing guidance
This peptide is not covered by FDA-labeled dosing guidance on this page. Peptides are often investigational or incompletely studied. Do not self-experiment; use only with a doctor or qualified clinician.
Typical dose
No FDA-approved dose exists; human trials used once-weekly escalation schedules, with phase 2 monotherapy ranging from 0.3 mg to 4.5 mg weekly and later development programs commonly including 2.4 mg weekly cagrilintide arms
Frequency
Once weekly in clinical-trial settings
Injection sites
Subcutaneous administration in trial programs
Best timing
Same day each week in trial protocols
Effects timeline
Appetite effects and gastrointestinal intolerance can appear early; weight-change endpoints are assessed over months
Storage
Do not assume a validated consumer storage or mixing protocol from gray-market listings; the reviewed source set centers on sponsor-supplied investigational injections, and FDA states cagrilintide cannot be used in compounding
Cycle length
Not a casual peptide cycle; human studies use ongoing weekly treatment schedules
Break between
Not established as a recreational or self-use protocol
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Quick Signals
At A Glance
A faster read on evidence, focus, structure, and status.
Evidence
Strong human research
Human clinical research exists for both standalone cagrilintide and cagrilintide-plus-semaglutide development, but the…
69 indexed studiesCurrent level
Human studies
Scale: low evidence to established use
Status
Regulatory and sport context
Safety
Side Effects And Safety
Switch between common side-effect notes and stop criteria to keep safety context visible.
Reported or plausible side effects
- Gastrointestinal adverse effects such as nausea, vomiting, diarrhea, and constipation are the main recurring issues in human studies, especially during dose escalation.
- If used with other glucose-lowering therapies, hypoglycemia monitoring may matter even though cagrilintide itself is not an insulin product.
Key cautions
- Injection-site reactions can occur with subcutaneous use.
- Appetite suppression is part of the intended mechanism but can become clinically problematic if oral intake or hydration drops too far.
- FDA states cagrilintide is not a component of an FDA-approved drug and cannot be used in compounding.
Molecule
Molecular Information
Core structure fields that help explain what kind of peptide this is and how much sequence detail is available.
Molecular weight
4,409 Da
Chain length
37 amino acids
Sequence type
Acylated long-acting amylin analogue
Derived from
Engineered analogue of human amylin
Amino acid sequence source string
Modified human amylin analogue with disulfide bonding and long-acting fatty-diacid acylation; the reviewed source set supports the molecular registry record more clearly than a simplified residue string.
Long-acting acylation plus peptide modifications that support extended exposure.
Context
Important Context
The main context that changes how confidently this peptide should be interpreted.
Research status
Human clinical research exists for both standalone cagrilintide and cagrilintide-plus-semaglutide development, but the major phase 3 efficacy headlines most often cited publicly belong to fixed-dose CagriSema rather than to standalone cagrilintide.
Regulatory and sport status
FDA review: reviewed openFDA queries did not identify an approved cagrilintide or CagriSema product. Sport review: the reviewed 2026 WADA list prohibits non-approved substances under S0, so athlete-specific review remains important while cagrilintide is investigational.
Blend composition
Single compoundSingle investigational long-acting amylin version; fixed-dose CagriSema is a separate combination product concept with semaglutide.
Route Notes
Route-Specific Notes
Only shown when the source material adds route-specific details beyond the quick-start guide.
Injectable
- Administration: Subcutaneous use is the route studied in human clinical trials.
- Absorption: Human evidence centers on once-weekly subcutaneous exposure as part of designed study programs.
- Cycle: Ongoing weekly treatment in trials rather than a casual cycle model.
- Additional: Regimen details should be read as investigational-study context rather than as consumer dosing advice.
- Availability: Not applicable
Compare
How Well Documented Is It?
A quick five-point snapshot of how visible and well-documented this peptide is. Higher values mean more coverage or clearer status in that area, not better medical performance.
Research
How much published research coverage this peptide has in the linked sources, with an approval-context floor for clearly established drug products.
Source: PubMed
Regulatory
How clearly the approval or regulatory status is documented for this entry.
Source: openFDA drugsfda API
Sport
How clearly sports or competition status is documented in the linked review sources.
Source: 2026 WADA Prohibited List PDF
Breadth
How broadly this peptide appears across discussion topics and use-case groupings in the catalog.
Source: Curated site taxonomy
Sequence
How much structure or residue-sequence detail is available for this entry.
Source: Catalog seed
Protocols
Research Protocols
Common protocol-style rows shown in a consistent table layout so every peptide page is easy to compare.
| Goal | Dose | Route | Frequency |
|---|---|---|---|
| Obesity monotherapy, phase 2 dose-finding | 0.3-4.5 mg | SubQ | 1x weekly |
| CagriSema combination development | 2.4 mg cagri + 2.4 mg sema | SubQ | 1x weekly |
| Later monocomponent comparison arms | 2.4 mg | SubQ | 1x weekly |
Research
What It Has Been Studied For
Plain-language summaries of the main health areas where this peptide shows up in the linked research.
Stacking
What People Commonly Stack It With
A plain-language view of compounds that are commonly discussed alongside this peptide in the source material.
Practical
Preparation, Quality, And Expectations
Operational checklist blocks designed for quick scanning and repeatable page structure.
How to reconstitute
- •No validated consumer reconstitution protocol was identified in the reviewed source set.
- •The reviewed evidence centers on sponsor-supplied investigational injections, not home-mixed lyophilized vials.
- •FDA states cagrilintide cannot be used in compounding under federal law.
- •Do not treat generic BAC-water instructions as cagrilintide-specific evidence.
Quality indicators
Good signs
- Source documentation clearly identifies cagrilintide as investigational.
- Trial or manufacturer handling instructions are followed exactly.
- Product origin, storage, and packaging are traceable.
Avoid
- Any claim that the ~22.7% phase 3 CagriSema result is a standalone cagrilintide result.
- Compounded, self-mixed, or research-chemical sourcing presented as routine therapeutic use.
- Unclear storage history or temperature excursions.
- Marketing that implies FDA approval or settled sports clearance.
What to expect
Appetite reduction and gastrointestinal tolerability issues may appear during escalation.
Progressive weight effects can emerge in clinical-trial settings.
Outcome size depends heavily on whether the data come from standalone cagrilintide or the fixed-dose CagriSema combination.
References
Research And Source List
Structured reference cards with source metadata and a direct link so users can inspect the original study/source.
Once-weekly cagrilintide for weight management in people with overweight and obesity
Lancet | 2021
Published phase 2 dose-finding monotherapy trial in people with overweight or obesity.
Cagrilintide plus semaglutide in type 2 diabetes
Lancet | 2023
Published phase 2 human combination trial using once-weekly cagrilintide and semaglutide.
CagriSema in obesity
NEJM | 2025
Phase 3 fixed-dose combination obesity trial showing that major late-stage efficacy headlines apply to CagriSema rather than to standalone cagrilintide.
CagriSema in type 2 diabetes and obesity
NEJM | 2025
Phase 3 fixed-dose combination trial in adults with type 2 diabetes and obesity.
Novo Nordisk Q4 2025 Investor Presentation
Company source | reviewed 2026-03-08
Company-reported material reviewed for the REDEFINE 1 cagrilintide monocomponent arm and the note that CagriSema was submitted to FDA in December 2025.
FDA concerns with unapproved GLP-1 drugs
FDA | current page
FDA page stating that cagrilintide cannot be used in compounding and has not been found safe and effective for any condition.
PubChem compound record
PubChem
Registry record for cagrilintide supporting the formula and molecular-weight fields.
openFDA cagrilintide query
FDA database | 2026 access
Reviewed approval-database query returning no FDA-approved cagrilintide match.
openFDA CagriSema query
FDA database | 2026 access
Reviewed approval-database query returning no FDA-approved CagriSema match.
2026 WADA Prohibited List PDF
WADA | 2026
Current prohibited-list PDF showing the S0 rule for non-approved substances.
PubMed: Once-weekly cagrilintide for weight management
Published phase 2 dose-finding monotherapy trial in people with overweight or obesity.
PubMed: Cagrilintide plus semaglutide in type 2 diabetes
Published phase 2 human combination trial using once-weekly cagrilintide and semaglutide.