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Home / Peptides / Desmopressin

FDA and NIH data · updated 2026-10-16

Desmopressin: FDA status and clinical evidence

FDA-approved

Desmopressin is approved by the FDA and is on the US market, first approved February 21, 1978, under 38 applications. 127 studies are registered on ClinicalTrials.gov, reaching Phase 4. 9 unexpired patents are listed in the Orange Book.

Yes
FDA-approved
127
Registered studies
Phase 4
Highest phase
38
FDA applications

FDA approval status

Status
Approved
First approval
February 21, 1978
Most recent approval
February 27, 2026
Applications on file
38
Brand names
CONCENTRAID, DDAVP, DDAVP (NEEDS NO REFRIGERATION), DESMODA, DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE PRESERVATIVE FREE, MINIRIN and 4 more
Sponsors
ABHAI LLC, ACERUS PHARMS, ACTAVIS LABS FL INC, AM REGENT, APOTEX, AUROBINDO PHARMA, BAUSCH, BEDFORD and 20 more
Routes
INJECTION, NASAL, ORAL, SUBLINGUAL
Dosage forms
INJECTABLE, SOLUTION, SPRAY, METERED, TABLET
Marketing status
Discontinued, Prescription
Reference listed drug
Yes
Orphan designation
Yes
Priority review
Yes

FDA review documents

Clinical evidence

Registered studies
127
Interventional
103
Completed
65
Currently active
16
Studies with posted results
19
Highest phase reached
Phase 4
Total enrolment across studies
1,128,083

By phase

Phase 429
Not applicable28
Phase 323
Phase 219
Phase 16

Full trial breakdown for Desmopressin →

Patents and generic availability

Listed in the Orange Book
Yes
Brand applications
12
Generic applications
28
Unexpired patents
9
Earliest protection expiry
May 21, 2029

When generic Desmopressin can launch →

Molecular identity

Substance class
Chemical
FDA UNII
ENR1LLB0FP
CAS number
16679-58-6
WHO ATC code
Recorded synonyms
12

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 Desmopressin, 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 Desmopressin FDA-approved?

Yes. Desmopressin 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 Desmopressin?

127 studies are registered on ClinicalTrials.gov with Desmopressin as an intervention, 65 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.

What brand names is Desmopressin sold under?

FDA records list CONCENTRAID, DDAVP, DDAVP (NEEDS NO REFRIGERATION), DESMODA, DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE PRESERVATIVE FREE, MINIRIN, NOCDURNA, NOCTIVA, STIMATE, STIMATE (NEEDS NO REFRIGERATION). 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.