Metabolic
Cagrilintide / CagriSema
amylin analog · cagrilintide + semaglutide
High metabolic-watcher interest; momentum dented when REDEFINE-4 MISSED vs tirzepatide (23 Feb 2026); Barclays cut peak sales $12B->$2B. NDA filed Dec 2025; decision ~Oct 2026.
Evidence
Bhuman trials
Status
Investigationalas of 2026-06
Approval
Not approved
Category
Metabolic
Route
Subcutaneous
Demand rank
honorable mention
01Dosing & Protocol
Typical · reference only
Trial target 2.4 mg weekly after ~16-wk co-titration; gray-market copies the 2.4 mg target
Titration
Reconstitution — illustrative, not a recommendation
5 mg vial + 2 mL BAC = 2.5 mg/mL; 2.4 mg = 96 U; 0.25 mg start = 10 U on U-100.
Reconstitution calculatorlive tool
96units
on a U-100 syringedraw to the 96 mark
Concentration2.5 mg/mL
Draw volume0.96 mL
Illustrative, not a recommendation. mg vs mcg confusion drives 5–1000× overdoses — always recompute for your own vial and syringe.
Units are not milligrams. mg-vs-mcg confusion drives documented 5–1000× overdoses — always recompute for your own vial.
02Regulatory Status
Removal from Category 2 ≠ legal to compound ≠ FDA-approved. Only legal access is a registered trial; gray-market vials are unapproved.
Pre-clinical
Phase 1
Phase 2
Phase 3
Approved
Status
Investigational
503A bulks
Not on the bulks list
Category 2
n/a (investigational; cannot be compounded; NOT in the Apr 2026 removals)
PCAC review
none scheduled
WADA
Not listed
03Evidence — the honest read
What the evidence actually shows
Multiple completed Phase 3 RCTs (REDEFINE 1/2 strong; REDEFINE 4 missed non-inferiority vs tirzepatide). Not approved.
04Safety
Contraindications
- MTC/MEN-2 (semaglutide component)
- Pregnancyhard stop
- Pancreatitis history
- Investigational - any gray-market use contraindicated
Key interactions
- Insulin/sulfonylureas -> hypoglycemia
- Stacking with gray semaglutide/tirzepatide -> additive GI/hypoglycemia/gallstone risk
Serious signals
- Thyroid C-cell boxed-warning (component)
- High injection-site reactions (~43% at 4.5 mg)
- GI ~80%
Monitoring
Glucose; GI tolerability; injection-site rotation.
05Related in Metabolic
Semaglutide
FDA-approved RCTs
grade A →Tirzepatide
FDA-approved RCTs
grade A →Retatrutide
human trials
grade B →MOTS-c
animal-only
grade D →06Sources
The primary sources behind this monograph — each opens the registry so you can verify the claim yourself. Last verified 2026-06-13.
SecondaryREDEFINE trialTrial coverage (secondary → registry) · REDEFINEHow we source & verify — the full method →Beyond these primaries, every monograph is distilled from TrackurStack’s research dossier — 584 de-duplicated sources across 4 research iterations, adversarially verified against primary sources.
Not medical or legal advice. Educational / harm-reduction reference. Regulatory and dosing claims in this field move monthly — re-verify against primary sources (FDA docket FDA-2025-N-6895, DailyMed, ClinicalTrials.gov) before acting.
Last reviewed — 2026-06-13 · confidence: high (trial) / low (gray-market)