Drugs / alitretinoin
alitretinoin
also known as
9-cis-retinoic acid · 9-cis-retinoic-acid (9-cis-RA)(Alitretinoin, Toctino) · AGN 192013 · Alitretinoina · Alitretinoine · ALRT-1057 · BAL4079 · LG-100057 · +5 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Panretin | — | 2000-10-11 | europa.eu ↗ |
| Approved | US (FDA) | PANRETIN | — | 1999-02-02 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT01245140 Comparator | Apr 2011 → Mar 2014 | psoriasis | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 3 | NCT05259722 Comparator | Jun 2022 → Nov 2023 | — | LEO Pharma | Completed | Met primary |
| 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 4 | NCT01231854 Comparator | Nov 2010 → Mar 2012 | atopic eczema | Technical University Dresden | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-06-25 | LEO Pharma | Results LEO Pharma to showcase new data highlighting the burden and unmet needs in Chronic Hand Eczema at ESCD 2026 in Copenhagen leo-pharma.com ↗
Patient reported outcomes from DELTA FORCE further demonstrated greater improvements in self-rated work productivity and daily activities in patients treated with topical delgocitinib compared with patients treated with oral alitretinoin. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-25 | LEO Pharma | LEO Pharma to showcase new data highlighting the burden and unmet needs in Chronic Hand Eczema at ESCD 2026 in Copenhagen leo-pharma.com ↗ |
| 2016-01-22 | Basilea Pharmaceutica | GSK informs Basilea that it has elected not to continue its U.S. alitretinoin program basilea.com ↗ |
| 2015-11-23 | Almirall, S.A. | Almirall has acquired the rights to Veltin® and Altabax® from Stiefel, a GSK company, in exchange for its distribution rights to Toctino® almirall.com ↗ |
| 2012-06-11 | GlaxoSmithKline | Stiefel signs worldwide acquisition and license agreement for Toctino® gsk.com ↗ |
| 2010-06-15 | Almirall, S.A. | Almirall announces an international agreement with Basilea to commercialize Toctino® (alitretinoin) for severe chronic hand eczema almirall.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited 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 |
| 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 |
| 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 ↗ |