Drug

Alprostadil

As of the edition of 20 October 2026, Alprostadil is a small molecule: marketed, first approved in 1982 (US); acts on PTGER1 and PTGER2; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2014
Kind
Small molecule
Brand name
Prostin Vr Pediatric
First approved
1 January 1982 (US)
Approvals on record
31 in 6 regions
Holder of the most recent approval
Pfizer; 4 holders in all
Registered trials
30, 6 stopped early
Disease areas
Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Hormones; Eye; Inherited and neonatal

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

2 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

2 company-target rows are on route B because of Alprostadil.

Targets

GeneProteinUniProt
PTGER1Prostaglandin E2 receptor EP1 subtypeP34995
PTGER2Prostaglandin E2 receptor EP2 subtypeP43116

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated4300
Phase 13101
Phase 28202
Phase 33102
Phase 412501
All trials30

Who has held its approvals

CompanyRoleYears
VivusLater holder and Lead sponsor of trials1996 to now
UCBLater holder and Lead sponsor of trials1997 to now
EndoAcquired holder2024 to now
ViatrisAcquired holder2025 to now
PfizerApplicant