Drugs / alitretinoin

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Panretin 2000-10-11 europa.eu
Approved US (FDA) PANRETIN 1999-02-02 fda.gov

Trials 13 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00001504 May 1996 → Jan 2002 breast cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01261923 Dec 2010 → Aug 2011 liver disorder University Hospital, Gentofte, Copenhagen Completed No outcome recorded
Phase 24 trials
Phase 2 NCT05077813 Dec 2021 → Feb 2022 tuberculosis Kafrelsheikh University Unknown No outcome recorded
Phase 2 NCT01538732 Mar 2012 → Mar 2014 lichen planus University of Zurich Unknown No outcome recorded
Phase 2 NCT01407679 Aug 2011 → Apr 2014 cutaneous lupus erythematosus University Hospital Muenster Terminated No outcome recorded
Phase 2 NCT00002188 HIV infectious disease, Kaposi's sarcoma Anderson Clinical Research Completed No outcome recorded
Phase 36 trials
Phase 3 NCT05016349 Aug → Oct 2021 female breast carcinoma Mahmoud Ramadan mohamed Elkazzaz Unknown No outcome recorded
Phase 3 NCT00817063 Jan 2009 → Apr 2012 dermatitis Stiefel, a GSK Company Completed No outcome recorded
Phase 3 NCT00519675 May 2007 → ? dermatitis Basilea Pharmaceutica Completed No outcome recorded
Phase 3 NCT00309621 Apr 2006 → Apr 2007 hand dermatosis Basilea Pharmaceutica Completed No outcome recorded
Phase 3 NCT00124436 Mar 2005 → Jan 2007 hand dermatosis Basilea Pharmaceutica Completed No outcome recorded
Phase 3 NCT00124475 Dec 2004 → Oct 2006 hand dermatosis Basilea Pharmaceutica Completed No outcome recorded
Phase not applicable1 trial
NCT00002439 HIV infectious disease, Kaposi's sarcoma Anderson Clinical Research Completed No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT01245140 Comparator Apr 2011 → Mar 2014 psoriasis Stiefel, a GSK Company Completed No outcome recorded
Phase 33 trials
Phase 3 NCT05259722 Comparator Jun 2022 → Nov 2023 LEO Pharma Completed No outcome recorded
Phase 3 NCT03026946 Comparator May 2017 → Jul 2022 hand dermatosis University Medical Center Groningen Unknown No outcome recorded
Phase 3 NCT03026907 Comparator May 2016 → Dec 2019 hand dermatosis University Medical Center Groningen Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT01231854 Comparator Nov 2010 → Mar 2012 atopic eczema Technical University Dresden Terminated No outcome recorded

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as Alitretinoin “Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised,...” PMID 40252681 Apr 2025
14

NCT03026907

NCT01231854

NCT00002439

NCT03026946

NCT00817063

NCT00124475

NCT00519675

NCT01538732

NCT00309621

NCT00002188

NCT01245140

NCT00124436

NCT01261923

NCT01407679

Known as 9-cis retinoic acid “9-cis-retinoic acid, an active vitamin A metabolite and the ligand of RXR, assists VDR signaling and suppresses the degradation of circulating vitamin D.” NCT05077813
4

“Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy.” PMID 26507685 Oct 2015

NCT05077813

NCT00001504

NCT05016349

Known as 9-cis-retinoic-acid (9-cis-RA)(Alitretinoin, Toctino) “9-cis-retinoic-acid (9-cis-RA)(Alitretinoin, Toctino®)” NCT01261923
Known as AGN 192013 ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as Alitretinoina ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as Alitretinoine ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as ALRT-1057 ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as BAL4079 “A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema...” PMID 25607554 Oct 2014
Known as LG-100057 ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as LGD-1057 ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as NSC-659772 ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as Panretin ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as Retinoic acid 9-cis-form ChEMBL registry synonym — accepted as the source's own label CHEMBL705
Known as Toctino “oral alitretinoin (Toctino®)” NCT01407679
Modality Other / unclassified “The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.” NCT00124475
Route Oral oral 9-cis-retinoic acid daily” NCT00001504