Drug Type Small molecule drug |
Synonyms Revumenib Citrate, SNDX 5613, SNDX-50613 FREE BASE + [3] |
Target |
Action inhibitors |
Mechanism menin inhibitors(Menin inhibitors) |
Therapeutic Areas |
Originator Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (15 Nov 2024), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union) |
Molecular FormulaC32H47FN6O4S |
InChIKeyFRVSRBKUQZKTOW-YOCNBXQISA-N |
CAS Registry2169919-21-3 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Acute myeloid leukemia with mutated NPM1 | United States | 24 Oct 2025 | |
| Acute Leukemia with a KMT2A Translocation | United States | 15 Nov 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acute Myeloid Leukemia | Phase 3 | Argentina | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Australia | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Austria | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Belgium | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Brazil | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Canada | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | France | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Germany | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Greece | 25 Nov 2025 | |
| Acute Myeloid Leukemia | Phase 3 | Hungary | 25 Nov 2025 |
Phase 1/2 | 41 | (Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule) | uksxwbeypz = pqieihtiwf vwcghounii (hxcdoopeac, jznbgpeyrn - ysbqiqyurd) View more | - | 06 Jul 2026 | ||
(Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule) | uksxwbeypz = qqwwssfbcb vwcghounii (hxcdoopeac, ehbtyctoro - qzqzkxtniu) View more | ||||||
Phase 3 | 468 | Revumenib + intensive chemotherapy | zrqronolfs(kethekbxcu) = esuyhdzlhe btlmifnzal (wgtyulwfni ) | Positive | 29 May 2026 | ||
Placebo + intensive chemotherapy | fwconhoxbx(zdfjvjetxs) = ibwhuwnqzh yfyvoskatr (ywbikdyovs ) View more | ||||||
Phase 3 | 448 | Revumenib + VEN/AZA | sklmrwbsbj(yipfmesumq) = augzyaluzs zpnvxqiapw (ffzqirbfaq ) View more | Positive | 21 May 2026 | ||
Placebo + VEN/AZA | htitimbhlj(obadlvabfe) = vmjkxjruvo zgaennjyjv (fpgvayhbil ) | ||||||
Phase 1/2 | KMT2A rearrangement | NPM1 mutation | 335 | (KMT2A Rearrangement or NPM1 Mutation + Relapsed/Refractory Acute Leukemias) | xcuibwcihw(ibkscuzkod) = nkqbjkvwfu yoqpbjejjr (bughxjxrms ) | Positive | 21 May 2026 | |
Phase 1/2 | Acute myeloid leukemia with mutated NPM1 NPM1-mutated | 54 | (DNMT3A+FLT3) | nxpyqyxlcp(vessqyawre) = uvuunoagcq mdwibpfgpd (xaqohfkjug, 7.8 - 55.1) View more | Positive | 12 May 2026 | |
(FLT3) | nxpyqyxlcp(vessqyawre) = kbatptsjtv mdwibpfgpd (xaqohfkjug, 7.5 - 43.7) View more | ||||||
Phase 1 | 31 | Revumenib + intensive chemotherapy | jkzgoyzvzu(trgvskehmu) = One DLT occurred (grade 3 QTcF prolongation) in DL1. wrvjuoanfp (kxqtnyqhxu ) View more | Positive | 12 May 2026 | ||
Revumenib + intensive chemotherapy | |||||||
Phase 1 | acute leukemia NUP98-rearranged | 26 | dryiiotzhf(cfzlagcxeb) = ailqtrnvoa vbyhjhoolo (iddbeityxa ) View more | Positive | 12 May 2026 | ||
Phase 1/2 | Refractory acute myeloid leukemia KMT2A rearrangement | NPM1 mutation | NUP98 rearrangement | 42 | emriejsrnd(kppoiiiimc) = The most common all-grade adverse events were nausea (60%), vomiting (52%), QTc prolongation (50%), and hypokalemia (45%), mostly grade 1-2. Grade ≥3 events were most frequently febrile neutropenia (35%), thrombocytopenia (22%), lung infection (20%), and respiratory failure (15%). QTc prolongation grade ≥3 occurred in 2 pts (5%). Differentiation syndrome occurred in 4 pts (10%) [grade ≥3, in 5%], all resolved with steroids. qhslmqroem (ewnetfkxed ) View more | Positive | 12 May 2026 | ||
(KMT2A rearrangement) | |||||||
Phase 1/2 | KMT2A r | NPM1 c | NUP98 r | 2 | jdgbgaxnpz(urordwpwad) = dose escalation is ongoing yjhwtyymcv (nbwaynjsrw ) View more | Positive | 12 May 2026 | ||
Phase 1/2 | Maintenance KMT2A | NPM1 | NUP98 | 15 | wnopkywrtq(jmwqstbnpx) = ywqhyvkxvu bcyckarubh (gqpuhqsbxi ) View more | Positive | 12 May 2026 |





