FDA and NIH data · updated 2026-10-16

Oxytocin: FDA status and clinical evidence

FDA-approved

Oxytocin is approved by the FDA and is on the US market, first approved April 17, 1980, under 9 applications. 935 studies are registered on ClinicalTrials.gov, reaching Phase 4.

Yes

FDA-approved

935

Registered studies

Phase 4

Highest phase

FDA applications

FDA approval status

Status

Approved

First approval

April 17, 1980

Most recent approval

July 13, 2018

Applications on file

Brand names

OXYTOCIN, OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5%, OXYTOCIN 5 USP UNITS IN DEXTROSE 5%, PITOCIN, SYNTOCINON

Clinical evidence

Registered studies

935

Interventional

865

Completed

515

Currently active

129

Studies with posted results

162

Highest phase reached

Phase 4

Total enrolment across studies

349,972

By phase

Not applicable392

Phase 2183

Phase 4114

Phase 192

Phase 373

Full trial breakdown for Oxytocin →

Patents and generic availability

Listed in the Orange Book

Yes

Brand applications

Generic applications

Unexpired patents

None listed

When generic Oxytocin can launch →

Molecular identity

Substance class

Protein

FDA UNII

1JQS135EYN

CAS number

50-56-6

WHO ATC code

H01BB02

Amino acid sequence

CYIQNCPLG

Sequence length

9 residues

Molecular weight

1007 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 Oxytocin, 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 Oxytocin FDA-approved?

Yes. Oxytocin 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 Oxytocin?

935 studies are registered on ClinicalTrials.gov with Oxytocin as an intervention, 515 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.

What brand names is Oxytocin sold under?

FDA records list OXYTOCIN, OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5%, OXYTOCIN 5 USP UNITS IN DEXTROSE 5%, PITOCIN, SYNTOCINON. 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.