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Cagrilintide: status, evidence, storage and handling

What cagrilintide is, where its combination with semaglutide stands at FDA, and why standalone vials sold online are a different story.

Reviewed October 11, 2026InvestigationalNot FDA-approved4 min read
What it isLong-acting amylin analog
FDA statusUnder review as CagriSema
Human evidenceLarge Phase 3 trials
CompoundingNot allowed

What Cagrilintide is

Amylin is a hormone released alongside insulin after meals. It slows stomach emptying and signals fullness. Cagrilintide is Novo Nordisk's long-acting, injectable version of it.

Novo developed cagrilintide mainly as half of CagriSema, a weekly injection combining cagrilintide with semaglutide. Standalone cagrilintide is not being filed for approval.

Regulatory status in 2026

Cagrilintide is not approved on its own or as CagriSema. FDA's decision on CagriSema is expected in late 2026 and could come any week.

  1. Novo Nordisk submits CagriSema to FDA for weight management.

  2. CagriSema misses its goal of matching tirzepatide's weight loss in a head-to-head trial.

  3. FDA decision on CagriSema expected in the fourth quarter of 2026. Cagrilintide cannot legally be used in compounding.

Regulatory status can change. Check the sources linked at the bottom of this page before relying on anything here.

Claims vs. what the research shows

Cagrilintide has real Phase 3 data, mostly as part of CagriSema.

Common claim

Causes weight loss on its own.

What the evidence shows

Shown in trials, though less than semaglutide alone in the main CagriSema trial.

Strong human evidence
Common claim

CagriSema beats tirzepatide.

What the evidence shows

Not shown. It fell short of tirzepatide in a direct comparison.

Insufficient data
Common claim

Research cagrilintide is the same as Novo's.

What the evidence shows

No. Gray-market vials have not been evaluated by FDA.

Insufficient data

Storage and stability

Peptides break down with heat, light, moisture, and repeated freezing and thawing. Degraded product is one common reason two vials of the "same" peptide behave differently. These are general peptide handling practices. Your supplier's certificate of analysis or label takes priority.

Sealed powder (lyophilized)

  • Refrigerate at 36 to 46°F (2 to 8°C) for routine storage.
  • Freezer is generally used for long-term storage.
  • Keep in its original sealed vial, away from light.
  • Let a cold vial reach room temperature before opening to limit condensation.

After reconstitution

  • Keep refrigerated. Do not freeze.
  • Protect from light. Clear glass lets it through.
  • Opened multi-dose bacteriostatic water is typically discarded 28 days after first puncture.
  • Log the mix date so you know the vial's age at a glance.

Light exposure is easy to overlook in a fridge door that opens dozens of times a day. VIALTIGHT is building stackable cases that block light from every side. See vialtight.com for updates.

Reconstitution math

Concentration is just the amount of peptide divided by the volume of water added. On a U-100 insulin syringe, 100 units equals 1 mL, so each unit is 0.01 mL. Enter what is on your vial label and what you added to see the concentration.

2.5mg per mL
2,500mcg per mL
25mcg per syringe unit

This shows concentration only. It is not a dosing recommendation. VialTracker runs this math for every vial you log and keeps it with the vial's history.

Safety flags

It is not approved, so there is no legal source. Vials sold online as research chemicals are unapproved, not legal for human use, and may not contain what the label says.

Side effects seen in trials. Mainly nausea, vomiting, and other stomach and bowel symptoms, similar to GLP-1 drugs.

Stacking with semaglutide yourself is not CagriSema. CagriSema is a specific, tested formulation. Mixing separate gray-market vials is not equivalent.

FAQ

Is CagriSema approved?

Not as of early October 2026. A decision is expected by the end of the year. Check FDA's site for the latest.

Can cagrilintide be compounded?

No. FDA has said it cannot be used in compounding.

Does VialTracker tell me what to take?

No. VialTracker organizes the information you enter and runs the math. It does not recommend doses, products, or protocols.

Sources

  1. FDA: Concerns with unapproved GLP-1 drugs used for weight loss
  2. Novo Nordisk news

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