Rezlidhia

(Olutasidenib)

Phase 2Small molecule

RRigel Pharmaceuticals

Rezlidhia is one of 120 small molecule programs targeting Chronic Myelomonocytic Leukemia. It is currently in Phase 2.

Indications

Total Trials

Active Trials

119

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Chronic Myelomonocytic LeukemiaActive, not recruiting

Acute Myeloid LeukemiaRecruiting

Myelodysplastic SyndromesRecruiting

IDH1 MutationRecruiting

Mutant IDH1 Inhibitor OlutasidenibRecruiting

Chronic Myelomonocytic LeukemiaPhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

Myelodysplastic SyndromesPhase 2

Recruiting

IDH1 MutationPhase 2

Recruiting

Mutant IDH1 Inhibitor OlutasidenibPreclinical

Recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

32 2

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

31 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

28 4

Peony

Takeda

Phase 3

6 5

Novantrone

EMD Serono

Phase 3

19 6

Empaveli

Gilead

Phase 3

4 7

Zarnestra

KKura Oncology, Inc.

Phase 3

9 8

Intron a

Sanofi

Phase 3

1 9

Tibsovo

SServier

Phase 3

8 10

Caspofungin Acetate

Merck & Co.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Hematopoietic Cell Transplant

NCT06543381

Q2 2027

Post-ApprovalRecruiting

IDH1 Mutation

NCT07486713

Q1 2029

Phase 1Not yet recruiting

Acute Myeloid Leukemia

NCT07411586

Q2 2029

Phase 2Recruiting

Acute Myeloid Leukemia

NCT06782542

Phase 2Recruiting

Acute Myeloid Leukemia

NCT05564390

Phase 2Recruiting

Relapsed or Refractory

NCT07032727

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia5 trials

Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy

Recruiting·—·Phase 2·NCT06782542·16 enrolled

Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07411586·20 enrolled

Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy)

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07153497·132 enrolled

Show 2 more trials

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564390·2,000 enrolled

A Phase 2 Study of Olutasidenib in Combination With Azacitidine Followed by Olutasidenib Maintenance After Venetoclax Plus a Hypomethylating Agent Regimen (HMA-VEN) for IDH1-Mutated Acute Myeloid Leukemia (AML)

Recruiting·UUniversity of California, Davis·Phase 2·NCT07304011·28 enrolled

IDH1 Mutation2 trials

Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

Recruiting·RRigel Pharmaceuticals·Phase 4·NCT07486713·16 enrolled

Pilot Single Arm Phase 2 Study of Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

Recruiting·TTimothy Pardee·Phase 2·NCT07471841·25 enrolled

Relapsed or Refractory1 trial

Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07032727·68 enrolled

Chronic Myelomonocytic Leukemia1 trial

A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06597734·45 enrolled

Hematopoietic Cell Transplant1 trial

Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant

Recruiting·—·Phase 1·NCT06543381·15 enrolled

3 more indications

Myeloid Malignancies1 trial

A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06668584·31 enrolled

Myelodysplastic Syndromes1 trial

A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06566742·15 enrolled

Mutant IDH1 Inhibitor Olutasidenib1 trial

Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06445959·78 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 1, 2022

REZLIDHIA

NDA NDA215814

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Olutasidenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Olutasidenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Olutasidenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215814). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rezlidhia. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Rigel Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: RRigel Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Sep 18, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9834539Sep 18, 2035

11498913Sep 18, 2035

12275715Sep 18, 2035

10414752Sep 18, 2035

10550098Sep 18, 2035

9 more patents

12053463May 16, 2039

10959994May 16, 2039

10532047May 16, 2039

11376246May 16, 2039

11013734May 16, 2039

11013733May 16, 2039

11497743May 16, 2039

11738018Jul 17, 2039

11723905Nov 12, 2039

Rezlidhia

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q1 2029

Q2 2029

Trials by Indication[1]

Acute Myeloid Leukemia5 trials

IDH1 Mutation2 trials

Relapsed or Refractory1 trial

Chronic Myelomonocytic Leukemia1 trial

Hematopoietic Cell Transplant1 trial

Myeloid Malignancies1 trial

Myelodysplastic Syndromes1 trial

Mutant IDH1 Inhibitor Olutasidenib1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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