Approved regulatory verdict
Evidence outlook
Approved: a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed... (FDA)
This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.
Source for the program status
How the evidence outlook works ↗
Featured trials The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Acute Myeloid Leukemia · investigational · Featured evidence · 2 investigational Featured evidence · 2
Competitive landscape 61 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 60 same-indication; 11 further along in development.
Unlock with Research ↗ Drug Stage Modality Mechanism Evidence signal Reported efficacygraded featured trials Ivosidenib: this drug Phase 3 Small molecule Mutant IDH1 Olutasidenib Approved Small molecule Mutant IDH1 ASTX727 Approved Small molecule Decitabine/cedazuridine fixed combination (DNMT + CDA inhibition) Enasidenib Approved Small molecule IDH2 Gemtuzumab Ozogamicin Approved Antibody–drug conjugate CD33 Gilteritinib Approved Small molecule FLT3 Midostaurin Approved Small molecule FLT3;KIT;PKC;PDGFR Quizartinib Approved Small molecule FLT3 Revumenib Approved Small molecule Menin Tretinoin (Vesanoid)Approved Small molecule RARA (retinoic acid receptor alpha); degrades the PML-RARA fusion oncoprotein in APL Venetoclax Approved Small molecule BCL-2 Vyxeos Approved Small molecule DNA synthesis (cytarabine, antimetabolite) / Topoisomerase II 131I-Apamistamab Phase 3 Monoclonal antibody CD45 AK117 Phase 3 Monoclonal antibody CD47 APG-2575(Lisaftoclax ) Phase 3 Small molecule BCL-2 Azacitidine Phase 3 Small molecule DNMT1 (DNA methyltransferase 1)
…and 46 more. Research shows the complete landscape.
Research Unlock the full comparison Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Unlock with Research ↗ Upcoming events (31 total) Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (3) November 2026 (1) Phase 2 CRC, MSS, Metastatic Cancer Not yet recruiting
Est. primary completion 2026-11-01 ·
NCT06593548 ·
CT.gov ↗ What to watch December 2026 (2) Phase 1 Acute Myeloid Leukemia Recruiting
Est. primary completion 2026-12-31 ·
NCT02074839 ·
CT.gov ↗ What to watch Phase 1 Acute Myeloid Leukemia Recruiting
Est. primary completion 2026-12-31 ·
NCT05010772 ·
CT.gov ↗ What to watch 2027 (13) March 2027 (1) Phase 2 Chondrosarcoma, Chondrosarcoma, Grade 2, Chondrosarcoma, Grade 3, IDH1 Gene Mutation Active not recruiting
Est. primary completion 2027-03 ·
NCT04278781 ·
CT.gov ↗ What to watch April 2027 (3) Phase 2 Acute Myeloid Leukemia Active not recruiting
Est. primary completion 2027-04-02 ·
NCT03503409 ·
CT.gov ↗ What to watch Phase 3 Acute Myeloid Leukemia Active not recruiting
Est. primary completion 2027-04-17 ·
NCT03839771 ·
CT.gov ↗ What to watch Phase 1 Acute Myeloid Leukemia Recruiting
Est. primary completion 2027-04-21 ·
NCT05756777 ·
CT.gov ↗ What to watch May 2027 (2) Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2027-05-30 ·
NCT07607418 ·
CT.gov ↗ What to watch Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2027-05-31 ·
NCT07548710 ·
CT.gov ↗ What to watch June 2027 (1) Phase 3 Biliary Tract Neoplasms Recruiting
Est. primary completion 2027-06 ·
NCT05615818 ·
CT.gov ↗ What to watch September 2027 (2) Phase 1/2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2027-09-30 ·
NCT03471260 ·
CT.gov ↗ What to watch Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2027-09-30 ·
NCT05401097 ·
CT.gov ↗ What to watch October 2027 (1) Phase 3 Acute Myeloid Leukemia Recruiting
Est. primary completion 2027-10-15 ·
NCT05907057 ·
CT.gov ↗ What to watch November 2027 (2) Phase 3 Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), Myelodysplastic Syndromes (MDS) Recruiting
Est. primary completion 2027-11-01 ·
NCT06465953 ·
CT.gov ↗ What to watch Phase 1/2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2027-11-29 ·
NCT04774393 ·
CT.gov ↗ What to watch December 2027 (1) Phase 3 Cholangiocarcinoma Active not recruiting
Est. primary completion 2027-12-01 ·
NCT05876754 ·
CT.gov ↗ What to watch 2028 (7) January 2028 (3) Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2028-01 ·
NCT07392242 ·
CT.gov ↗ What to watch Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2028-01-01 ·
NCT06707493 ·
CT.gov ↗ What to watch Early phase / not applicable Acute Myeloid Leukemia Recruiting
Est. primary completion 2028-01-30 ·
NCT06265545 ·
CT.gov ↗ What to watch February 2028 (1) Phase 3 Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation … Recruiting
Est. primary completion 2028-02-01 ·
NCT06127407 ·
CT.gov ↗ What to watch May 2028 (1) Early phase / not applicable Acute Myeloid Leukemia Recruiting
Est. primary completion 2028-05-10 ·
NCT07131059 ·
CT.gov ↗ What to watch June 2028 (1) Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2028-06-01 ·
NCT04493164 ·
CT.gov ↗ What to watch July 2028 (1) Phase 1 IDH1-Mutated Malignancies Recruiting
Est. primary completion 2028-07-31 ·
NCT07006688 ·
CT.gov ↗ What to watch 2029 (3) April 2029 (1) Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2029-04 ·
NCT07507760 ·
CT.gov ↗ What to watch May 2029 (1) Phase 1 Myeloproliferative Neoplasms Recruiting
Est. primary completion 2029-05 ·
NCT06291987 ·
CT.gov ↗ What to watch October 2029 (1) Phase 2 Acute Myeloid Leukemia Recruiting
Est. primary completion 2029-10-01 ·
NCT06717958 ·
CT.gov ↗ What to watch 2030 (3) January 2030 (1) Phase 2 Clonal Cytopenia of Undetermined Significance Active not recruiting
Est. primary completion 2030-01-31 ·
NCT05030441 ·
CT.gov ↗ What to watch September 2030 (1) Phase 2 Acute Myeloid Leukemia Not yet recruiting
Est. primary completion 2030-09 ·
NCT07463768 ·
CT.gov ↗ What to watch December 2030 (1) Phase 2 Cholangiocarcinoma, IDH Mutation Recruiting
Est. primary completion 2030-12 ·
NCT07260175 ·
CT.gov ↗ What to watch 2032 (1) December 2032 (1) Phase 2/3 Acute Myeloid Leukemia Recruiting
Est. primary completion 2032-12 ·
NCT03013998 ·
CT.gov ↗ What to watch 2033 (1) July 2033 (1) Phase 3 Biliary Tract Cancer (BTC) Not yet recruiting
Est. primary completion 2033-07-02 ·
NCT07745296 ·
CT.gov ↗ What to watch See the full readout calendar ↗
All registered studies Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.
All indications (61) Acute Myeloid Leukemia (29) Other / comorbidity (32)
Phase 3 (9) Phase 2/3 (1) Phase 2 (22) Phase 1/2 (6) Phase 1 (20) Early phase / not applicable (3) Appears in other studies (1)