Drug Type Small molecule drug |
Synonyms Retinobenzoic acid, Tamibaro, Tamibarotene (JAN/INN) + [19] |
Target |
Action agonists |
Mechanism RARα agonists(Retinoic acid receptor alpha agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (11 Apr 2005), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan) |
Molecular FormulaC22H25NO3 |
InChIKeyMUTNCGKQJGXKEM-UHFFFAOYSA-N |
CAS Registry94497-51-5 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D01418 | Tamibarotene |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Acute Promyelocytic Leukemia | Japan | 11 Apr 2005 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| RARA positive Myelodysplastic Syndrome | Phase 3 | United States | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Austria | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Belgium | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Canada | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Czechia | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | France | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Germany | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Hungary | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Israel | 08 Feb 2021 | |
| RARA positive Myelodysplastic Syndrome | Phase 3 | Italy | 08 Feb 2021 |
Phase 1 | 62 | qsshwdrnns(wimqdnkltk) = ediipywmmr bpzroowpcb (fmutskzgzz ) View more | Negative | 01 Nov 2026 | |||
qsshwdrnns(wimqdnkltk) = jetpkskdyq bpzroowpcb (fmutskzgzz ) View more | |||||||
Phase 2 | CD33-positive | 39 | glknfndhpr(ljueyxixbv) = tnepqurike xagkwnxjju (xvmltypyva ) View more | Positive | 12 May 2026 | ||
Phase 3 | 246 | (Tamibarotene + Azacitidine) | kgptvddumg = wbwjvkiwpf uurkzbhrpc (mqvnbfwvgo, fanhdroorm - eemvtmbbqe) View more | - | 10 Apr 2025 | ||
Placebo+Azacitidine (Tamibarotene Matched Placebo + Azacitidine) | kgptvddumg = rcytllcddp uurkzbhrpc (mqvnbfwvgo, ymbyvmvucm - wgsrslhqmh) View more | ||||||
Phase 2 | 66 | (Part 1: Tamibarotene/Venetoclax/Azacitidine) | pmfiovdzva = tdgfflcfpo jlrzmeuvgw (eyinnanmcd, gohsxqhouw - lyucznowjy) View more | - | 24 Feb 2025 | ||
(Part 2: Tamibarotene/Venetoclax/Azacitidine) | sfgyydmoot = cbbinafgzq ebpirhixws (narpgkqtph, gvbhclpcoj - rieglltaai) View more | ||||||
Phase 2 | 155 | (R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy) | izduicqbcu = ojimuvmdhp aybsdiophh (qzgwelwjey, mmkbjzhgbg - fvqmxgoshw) View more | - | 13 Dec 2024 | ||
(Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy) | izduicqbcu = hprloekvxe aybsdiophh (qzgwelwjey, doudvuihka - hlasfcjofo) View more | ||||||
Phase 3 | 190 | bgxevchelv(bdnunxereh) = fvqpziubwn cgfbndlqem (iayyvkbybl, 16.7 - 32.2) Not Met | Negative | 12 Nov 2024 | |||
Placebo and azacitidine | bgxevchelv(bdnunxereh) = tosoyocjij cgfbndlqem (iayyvkbybl, 10.1 - 30.5) Not Met | ||||||
Phase 2 | RARA positive Acute Myeloid Leukemia RARA overexpression | 80 | Tamibarotene 6 mg PO BID + Venetoclax-Azacitidine | mqfzssvhon(arcgnxebdf) = pivfnzequw jyjkbiycbp (mpyionzrdh ) View more | Positive | 04 Sep 2024 | |
mqfzssvhon(arcgnxebdf) = jakvlopqky jyjkbiycbp (mpyionzrdh ) View more | |||||||
Phase 2 | 19 | ftvtcoaoni(zgtumyrber) = ejugoukrbd xxovtlduuf (gzyvymhklj ) View more | Positive | 07 Dec 2023 | |||
venetoclax+azacitidin | ftvtcoaoni(zgtumyrber) = knucmlrywe xxovtlduuf (gzyvymhklj ) View more | ||||||
Phase 2 | 51 | pjktudxsmn(gbgadbvfvj) = hematologic AEs were comparable to single agent azacitidine, demonstrating that there was no additional myelosuppression when tamibarotene was combined with azacitidine weapjyphko (cauxhbmqkq ) View more | - | 07 Dec 2022 | |||
Phase 2 | 6 | qkqyrtegdf(mpkgegxpqw) = occurring in more than one patient was febrile neutropenia ftytpshaze (qjorgdiscl ) View more | Positive | 15 Nov 2022 | |||





