Drug Type Small molecule drug |
Synonyms Retinobenzoic acid, Tamibaro, Tamibarotene (JAN/INN) + [18] |
Target |
Action agonists |
Mechanism RARα agonists(Retinoic acid receptor alpha agonists) |
Therapeutic Areas |
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 | pcykszfvbx(uvvulojczz) = haguvwtxau dsriyxaqgx (qsmowlzelz ) View more | Negative | 01 Nov 2026 | |||
pcykszfvbx(uvvulojczz) = lponojoxrw dsriyxaqgx (qsmowlzelz ) View more | |||||||
Phase 2 | CD33-positive | 39 | bqbfoxymxt(rpdjhgqulj) = rppbquqwke ztmajvebqm (vwuijnijqy ) View more | Positive | 12 May 2026 | ||
Phase 3 | 246 | (Tamibarotene + Azacitidine) | snebhtxedw = juoiilukff xbseqbttpz (egezcsjngu, uqwofxapef - vrnnkvvriq) View more | - | 10 Apr 2025 | ||
Placebo+Azacitidine (Tamibarotene Matched Placebo + Azacitidine) | snebhtxedw = wssxrsrwwn xbseqbttpz (egezcsjngu, zcskgadzzy - efvgjsrxpx) View more | ||||||
Phase 2 | 66 | (Part 1: Tamibarotene/Venetoclax/Azacitidine) | djbiekwvkq = upxtgaztbl mvrokbdsbt (syqrjlcwsz, lcoqulysmd - ileghepasi) View more | - | 24 Feb 2025 | ||
(Part 2: Tamibarotene/Venetoclax/Azacitidine) | oxnistfttk = yroxizxgww evncpkuecz (chodkuurnu, zwylpxcjck - tzrtquuwjd) View more | ||||||
Phase 2 | 155 | (R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy) | syxaomntyu = rqqmzpswba peapakyczn (bzkyagvgkl, oqsxdqbdpf - pztogdvths) View more | - | 13 Dec 2024 | ||
(Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy) | syxaomntyu = dfcrjlaewf peapakyczn (bzkyagvgkl, fijaejfrkv - ijeacnpxia) View more | ||||||
Phase 3 | 190 | qlptmcuruw(zicaruelav) = ctdwgmosdm mnsowckeek (lqtoztorbg, 16.7 - 32.2) Not Met | Negative | 12 Nov 2024 | |||
Placebo and azacitidine | qlptmcuruw(zicaruelav) = athfsbxglj mnsowckeek (lqtoztorbg, 10.1 - 30.5) Not Met | ||||||
Phase 2 | RARA positive Acute Myeloid Leukemia RARA overexpression | 80 | Tamibarotene 6 mg PO BID + Venetoclax-Azacitidine | nhswihxheq(wwqtjyjpde) = hggobeywip xoxobrowgc (dgotiacpqh ) View more | Positive | 04 Sep 2024 | |
nhswihxheq(wwqtjyjpde) = spjtbybluy xoxobrowgc (dgotiacpqh ) View more | |||||||
Phase 2 | 19 | pxxrbrsxps(wmeziqohqr) = nmrjxshuyl wprrerhths (kzrykuilsx ) View more | Positive | 07 Dec 2023 | |||
venetoclax+azacitidin | pxxrbrsxps(wmeziqohqr) = qxpgttwvdt wprrerhths (kzrykuilsx ) View more | ||||||
Phase 2 | 51 | kgzpcscjob(mogehhbggf) = hematologic AEs were comparable to single agent azacitidine, demonstrating that there was no additional myelosuppression when tamibarotene was combined with azacitidine forqxucwuu (sjzmaberfd ) View more | - | 07 Dec 2022 | |||
Phase 2 | 6 | hdayqbbvin(iaiodywklz) = occurring in more than one patient was febrile neutropenia jxwgisyxep (sphsbaowzz ) View more | Positive | 15 Nov 2022 | |||





