Drug

Iloprost

As of the edition of 20 October 2026, Iloprost is a small molecule: marketed, first approved in 1992 (FR); acts on PTGIR; no US protection of its own is listed.

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

The drug

Status
Marketed; latest approval 2015
Kind
Small molecule
Brand name
Ventavis
First approved
16 June 1992 (FR)
Approvals on record
11 in 7 regions
Holder of the most recent approval
Btg; 4 holders in all
Registered trials
77, 16 stopped early
Disease areas
Lungs and airways; Heart and blood vessels; Cancer; Infections; Inherited and neonatal; Blood and lymph

US protection

No US protection of its own is listed.

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

Btg holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original drug.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Iloprost.

Target

GeneProteinUniProt
PTGIRProstacyclin receptorP43119

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated272013
Phase 15301
Phase 2221217
Phase 3151012
Phase 48213
All trials77

Who has held its approvals

CompanyRoleYears
BayerApplicant and Lead sponsor of trials1992 to now
Johnson & JohnsonAcquired holder and Lead sponsor of trials2004 to now
BtgAcquired holder2024 to now