Drug Type Small molecule drug |
Synonyms Idasanutlin (USAN/INN), RG-7388, RO-5503781 |
Target |
Action inhibitors |
Mechanism MDM2 inhibitors(p53-binding protein Mdm-2 inhibitors) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
Drug Highest PhaseDiscontinuedPhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States) |
Molecular FormulaC31H29Cl2F2N3O4 |
InChIKeyTVTXCJFHQKSQQM-LJQIRTBHSA-N |
CAS Registry1229705-06-9 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Refractory acute myeloid leukemia | Phase 3 | United States | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Australia | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Austria | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Belgium | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Canada | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Finland | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | France | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Germany | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Israel | 30 Dec 2015 | |
Refractory acute myeloid leukemia | Phase 3 | Italy | 30 Dec 2015 |
NCT02670044 (Pubmed) Manual | Phase 1 | 50 | mvzpcpkasc(kfxcwwuhhn) = diarrhea (87.3% of patients), nausea (74.5%), vomiting (52.7%), hypokalemia (50.9%), and febrile neutropenia (45.5%) nafiylutdd (koaujuwmhj ) | Positive | 20 Oct 2022 | ||
Phase 1/2 | 24 | (Dose-Escalation Cohort 1) | lhoxdgqqze = rpvsqirvkq pmdyseofsq (zffiietdfp, jvfcnqnrrd - rflyqckgqb) View more | - | 21 Jun 2022 | ||
(Dose Escalation Cohort 2) | lhoxdgqqze = ptqsznzowq pmdyseofsq (zffiietdfp, jteujwtttl - ftmpnnuuvv) View more | ||||||
Phase 3 | Acute Myeloid Leukemia First line | Second line | Third line | 447 | igtzwgiron(dvvscudeep) = xxxvuibwex yesogjvcbg (jjclenxxph ) View more | Negative | 12 Apr 2022 | ||
Cytarabine+Placebo | igtzwgiron(dvvscudeep) = froqnhaifx yesogjvcbg (jjclenxxph ) View more | ||||||
NCT03287245 (Pubmed) Manual | Phase 2 | 16 | mfgffewwnp(qfcnwintcq) = vpiohvrvlp ehooapnejb (sdloyzhncm ) View more | Positive | 22 Feb 2022 | ||
Phase 3 | 447 | Placebo+Cytarabine (Placebo Plus Cytarabine) | kxhawuysqp(yfiilngiip) = faximyujac udrcqjtwzw (ghazilmwkc, xqleoxdmoz - bdpmzzczvf) View more | - | 14 Sep 2021 | ||
(Idasanutlin Plus Cytarabine) | kxhawuysqp(yfiilngiip) = nmafxhkqdc udrcqjtwzw (ghazilmwkc, ijrrarzuxm - ohhirzgfhc) View more | ||||||
Phase 1/2 | 12 | aqnmozejcn = xklahngfwc tjplahdtla (dqcjaugoat, ywrbktxwtz - pmixiwtdek) View more | - | 11 Aug 2021 | |||
Phase 1 | 122 | overall | pigoxdtdgz(buicmoxama) = The RDE was determined as 600 mg twice a day for the MBP formulation and 300 mg twice a day for the SDP formulation. zptadmbzxj (uayhpcluro ) View more | Positive | 01 Jan 2021 | ||
(TP53 wild-type pts) | |||||||
Phase 1/2 | 29 | smuyrccqzd(etueoicplo) = 48.3% [neutropenia (10.3%)] xbfufssjkh (sntxfeodrj ) View more | Positive | 05 Nov 2020 | |||
Phase 2 | 25 | icxvhseboe(qnbvcgbkvk) = All FL or DLBCL pts had ≥ 1 AE. 79.2% had ≥ 1 Grade 3/4 AEs, most commonly thrombocytopenia (75%), neutropenia (62.5%) and anaemia (37.5%). No Grade 5 AEs were reported. 37.5% of pts experienced SAEs, most commonly febrile neutropenia (8.3%) and diarrhoea (8.3%). Dose-limiting toxicity events were all Grade 3/4 thrombocytopenia. 37.5% of pts had an AE leading to withdrawal of study treatment, most commonly thrombocytopenia (25%) and neutropenia (8.3%). iurzrfqufn (cyubneiysy ) | - | 14 May 2020 | |||
Phase 1 | 49 | yeguagjklz(asowrtowsh) = febrile neutropenia (45%), neutropenia (27%), and thrombocytopenia (25%) eavmvrcbkd (kbughwtjcx ) View more | Positive | 13 Nov 2019 |