Drugs / Acitretin

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) SORIATANE — 1996-10-28 fda.gov ↗

Trials 18

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03753867 Jan → May 2019 HIV infectious disease Ottawa Hospital Research Institute Withdrawn No outcome recorded
Phase 23 trials
Phase 2 NCT02715960 Dec 2015 → Dec 2017 psoriasis Central South University Unknown No outcome recorded
Phase 2 NCT02050321 Dec 2013 → Dec 2014 melanoma University of Arizona Terminated No outcome recorded
Phase 2 NCT00156247 Sep 2005 → Mar 2009 psoriasis University of Medicine and Dentistry of New Jersey Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01545284 Mar 2012 → Jan 2014 hand dermatosis Innovaderm Research Inc. Completed No outcome recorded
Phase 31 trial
Phase 3 NCT00002143 — HIV infectious disease, psoriasis Hoffmann-La Roche Completed No outcome recorded
Phase 48 trials
Phase 4 NCT06998875 Mar → Oct 2025 overdue primary cutaneous amyloidosis Army Medical University, China Recruiting No outcome recorded
Phase 4 NCT02181790 Jun → Dec 2014 psoriasis Icahn School of Medicine at Mount Sinai Terminated No outcome recorded
Phase 4 NCT01299220 Nov 2010 → Sep 2011 exanthem University of Pittsburgh Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT01228409 Oct 2010 → Dec 2011 psoriasis Frankel, Amylynne, M.D. Unknown No outcome recorded
Phase 4 NCT00832364 Oct 2009 → Mar 2010 psoriasis Stiefel, a GSK Company Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT00707070 Sep 2008 → Oct 2009 psoriasis University of Verona Unknown No outcome recorded
Phase 4 NCT00488384 Jun 2007 → Dec 2014 squamous cell carcinoma Günther Hofbauer Withdrawn No outcome recorded
Phase 4 NCT00723437 Jan 2005 → Jan 2007 psoriasis Istituti Fisioterapici Ospitalieri Completed No outcome recorded
Phase not applicable4 trials · 1 missed
— NCT04245319 Jan 2020 → Nov 2021 depressive disorder, hyperlipidemia, liver disorder Cairo University Unknown No outcome recorded
— NCT01094717 Jan 2010 → Sep 2011 psoriasis University of Utah Terminated No outcome recorded Stop: Business
— NCT00644384 Feb 2003 → May 2006 skin carcinoma Mayo Clinic Completed No outcome recorded
— NCT00003611 May 2000 → Feb 2003 epithelial skin neoplasm Alliance for Clinical Trials in Oncology Completed Missed primary
Comparator or background therapy13 trials
Phase 1 NCT05184348 Comparator Sep 2021 → Jan 2023 psoriasis South Valley University Completed No outcome recorded
Phase 2 NCT06739551 Comparator Dec 2024 → Mar 2025 overdue lichen planus Sheikh Zayed Medical College Not yet recruiting No outcome recorded
Phase 2 NCT01078168 Comparator Mar 2010 → Jan 2013 Alzheimer disease K. Lieb Completed No outcome recorded
Phase 2 NCT00395941 Comparator Dec 2006 → Dec 2008 psoriasis Post Graduate Institute of Medical Education and Research, Chandigarh Completed No outcome recorded
Phase 4 NCT07708480 Comparator Dec 2024 → May 2025 hidradenitis suppurativa Hayat Abad Medical Complex, Peshawar Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2024-08-01 Alembic Pharmaceuticals Ltd. Regulatory 7th August, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 33 sources stand behind the page.

FieldValueCited text
Known as acitretin ClinicalTrials.gov intervention name — accepted as the source's own label NCT00156247 ↗
30

NCT00723437 ↗

NCT00936065 ↗

NCT01443338 ↗

NCT00002143 ↗

NCT01094717 ↗

NCT05184348 ↗

NCT00003611 ↗

NCT05203354 ↗

NCT00395941 ↗

NCT02715960 ↗

Show 20 more sources

Known as Acitretin 25Mg Cap “Drug: Acitretin 25Mg Cap” NCT05401006 ↗
Known as Acitretina ChEMBL registry synonym — accepted as the source's own label CHEMBL1131 ↗
Known as Acitretine ChEMBL registry synonym — accepted as the source's own label CHEMBL1131 ↗
Known as Etretin ChEMBL registry synonym — accepted as the source's own label CHEMBL1131 ↗
Known as Neotigason ChEMBL registry synonym — accepted as the source's own label CHEMBL1131 ↗
Known as RO 10-1670 ChEMBL registry synonym — accepted as the source's own label CHEMBL1131 ↗
Known as RO 10-1670/000 ChEMBL registry synonym — accepted as the source's own label CHEMBL1131 ↗
Known as Soriatane “Acitretin will be provided to participants in the formulation Soriatane.” NCT03753867 ↗
Known as U0279 “Drug: Acitretin (also called U0279)” NCT00832364 ↗
Action Activate “enhancement of the α-secretase activity by acitretin” NCT01078168 ↗
Modality Small molecule “acitretin, a synthetic retinoid” NCT00644384 ↗
Route Oral “receive either placebo or acitretin 25 mg orally 5 days per week.” PMID 21882176 ↗ Aug 2011