PepTrackevidence-graded reference
Cagrilintide / CagriSema
fig.1 — stylized molecular motif
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
0.250.511.72.4 mg↑ dose · → time (≈4-week steps)
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.
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
1Novo Nordisk REDEFINE releases
＋PepTrack research dossier — iterations 1–4, 584 de-duplicated sources, adversarially verified.
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)
← All peptides
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
B
human trials
Status
Investigational
as of 2026-06
FDA approval
Not approved
off-label / gray
Route
Subcutaneous
Community / anecdotal
Demand
—
honorable mention
WADA
Not listed
sport-legal
01

Dosing & protocol

Community / anecdotal. Community / anecdotal — no regulatory basis. Not medical advice.
Typical — reference only

Trial target 2.4 mg weekly after ~16-wk co-titration; gray-market copies the 2.4 mg target

Worked reconstitution example

5 mg vial + 2 mL BAC = 2.5 mg/mL; 2.4 mg = 96 U; 0.25 mg start = 10 U on U-100.

Titration
00.61.21.82.40.25wk 10.5wk 51wk 91.7wk 132.4 mgwk 17dose (mg) ↑time → (≈4-week steps)
Units are not milligrams. mg-vs-mcg confusion drives documented 5–1000× overdoses — always recompute for your own vial (use the calculator →).
02

Regulatory 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
StatusInvestigational
503A bulksNot on the bulks list
Category 2 (2026)n/a (investigational; cannot be compounded; NOT in the Apr 2026 removals)
PCAC reviewnone scheduled
WADANot listed
03

Evidence — the honest read

Bhuman trials

Multiple completed Phase 3 RCTs (REDEFINE 1/2 strong; REDEFINE 4 missed non-inferiority vs tirzepatide). Not approved.

04

Safety

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.

06

Sources

01Novo Nordisk REDEFINE releases
＋PepTrack research dossier — iterations 1–4, 584 de-duplicated sources, adversarially verified.
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)