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Home / Peptides / Glucagon

FDA and NIH data · updated 2026-10-16

Glucagon: FDA status and clinical evidence

FDA-approved

Glucagon is approved by the FDA and is on the US market, first approved November 14, 1960, under 12 applications. 1516 studies are registered on ClinicalTrials.gov, reaching Phase 4. 8 unexpired patents are listed in the Orange Book.

Yes
FDA-approved
1516
Registered studies
Phase 4
Highest phase
12
FDA applications

FDA approval status

Status
Approved
First approval
November 14, 1960
Most recent approval
September 15, 2025
Applications on file
12
Brand names
BAQSIMI, GLUCAGEN, GLUCAGON, GVOKE HYPOPEN, GVOKE KIT, GVOKE PFS, GVOKE VIALDX
Sponsors
AMPHASTAR PHARMS INC, CIPLA, FRESENIUS KABI USA, LILLY, LUPIN, MYLAN LABS LTD, NOVO NORDISK, QUAD PHARMS and 1 more
Routes
INJECTION, INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, Injection, NASAL, SUBCUTANEOUS
Dosage forms
INJECTABLE, Injectable, POWDER, SOLUTION
Marketing status
Discontinued, Prescription
Reference listed drug
Yes
Priority review
Yes

FDA review documents

Clinical evidence

Registered studies
1516
Interventional
1339
Completed
793
Currently active
366
Studies with posted results
320
Highest phase reached
Phase 4
Total enrolment across studies
10,847,447

By phase

Not applicable343
Phase 2303
Phase 4249
Phase 3245
Phase 1241

Full trial breakdown for Glucagon →

Patents and generic availability

Listed in the Orange Book
Yes
Brand applications
7
Generic applications
4
Unexpired patents
8
Exclusivity periods
2
Earliest protection expiry
March 17, 2028

When generic Glucagon can launch →

Molecular identity

Substance class
Protein
FDA UNII
76LA80IG2G
CAS number
16941-32-5
WHO ATC code
Amino acid sequence
HSQGTFTSDYSKYLDSRRAQDFVQWLMNT
Sequence length
29 residues
Molecular weight
3480 g/mol
Recorded synonyms
17

From the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.

How to read this. This page reports what federal records say about Glucagon, nothing more. An FDA approval covers specific uses and doses on a reviewed label. A registered trial records that research was declared, not that it succeeded. A listed patent governs who may sell a drug, not whether it works. None of this is medical advice, and none of it means a compound is safe to use outside a prescription.

Frequently asked questions

Is Glucagon FDA-approved?

Yes. Glucagon holds FDA approval and is marketed in the US. Approval covers the specific uses, doses and forms on the FDA label, not every use it is sold or discussed for.

How much clinical research is there on Glucagon?

1516 studies are registered on ClinicalTrials.gov with Glucagon as an intervention, 793 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.

What brand names is Glucagon sold under?

FDA records list BAQSIMI, GLUCAGEN, GLUCAGON, GVOKE HYPOPEN, GVOKE KIT, GVOKE PFS, GVOKE VIALDX. Brand availability changes over time, and some applications on file are marked discontinued.

Where does the information on this page come from?

Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.

Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.