FDA and NIH data · updated 2026-10-16

Pramlintide: FDA status and clinical evidence

Approved, not currently marketed

Pramlintide holds FDA approval, but every application on record is marked discontinued, so it is not currently marketed in the US. 64 studies are registered on ClinicalTrials.gov, reaching Phase 4.

Was

FDA-approved

Registered studies

Phase 4

Highest phase

FDA applications

FDA approval status

Status

Approved

First approval

March 16, 2005

Most recent approval

March 16, 2005

Applications on file

Brand names

SYMLIN

Clinical evidence

Registered studies

Interventional

Completed

Currently active

Studies with posted results

Highest phase reached

Phase 4

Total enrolment across studies

5,944

By phase

Not applicable20

Phase 219

Phase 410

Phase 38

Phase 18

Full trial breakdown for Pramlintide →

Patents and generic availability

Listed in the Orange Book

Yes

Brand applications

Unexpired patents

None listed

When generic Pramlintide can launch →

Molecular identity

Substance class

Protein

FDA UNII

D3FM8FA78T

CAS number

151126-32-8

WHO ATC code

A10BX05

Amino acid sequence

KCNTATCATQRLANFLVHSSNNFGPILPPTNVGSNTY

Sequence length

37 residues

Molecular weight

3950 g/mol

Recorded synonyms

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 Pramlintide, 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 Pramlintide FDA-approved?

Pramlintide was approved by the FDA, but every application on record is marked discontinued, so it is not currently marketed in the US.

How much clinical research is there on Pramlintide?

64 studies are registered on ClinicalTrials.gov with Pramlintide as an intervention, 43 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.

What brand names is Pramlintide sold under?

FDA records list SYMLIN. 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.