Drug

Acitretin

As of the edition of 20 October 2026, Acitretin is a small molecule: marketed, first approved in 1988 (FR); acts on RARA, RARB and RARG and 3 more.

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

The drug

Status
Marketed; latest approval 2018
Kind
Small molecule
Brand name
Soriatane
First approved
12 September 1988 (FR)
Approvals on record
9 in 5 regions
Holder of the most recent approval
TEVA FARMACÊUTICA LTDA.; 5 holders in all
Registered trials
21, 7 stopped early
Disease areas
Skin and connective tissue; Cancer; Immune system; Infections; Urinary and reproductive; Digestive system

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

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

Companies on route B for this drug

In the product

6 company-target rows are on route B because of Acitretin.

Targets

GeneProteinUniProt
RARARetinoic acid receptor alphaP10276
RARBRetinoic acid receptor betaP10826
RARGRetinoic acid receptor gammaP13631
RXRARetinoic acid receptor RXR-alphaP19793
RXRBRetinoic acid receptor RXR-betaP28702
RXRGRetinoic acid receptor RXR-gammaP48443

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated6401
Phase 11001
Phase 23101
Phase 32200
Phase 49214
All trials21

Who has held its approvals

CompanyRoleYears
AbbVieApplicant1994 to now
RocheApplicant and Lead sponsor of trials1996 to now
StiefelAcquired holder2008 to now