CLINICAL TRIALS PROFILE FOR OLUTASIDENIB

All Clinical Trials for Olutasidenib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02719574 ↗	Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation	Recruiting	Forma Therapeutics, Inc.	Phase 1/Phase 2	2016-04-01	This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
NCT06161974 ↗	Study of Olutasidenib and Temozolomide in HGG	Not yet recruiting	Nationwide Children's Hospital	Phase 2	2024-06-01	The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
NCT06161974 ↗	Study of Olutasidenib and Temozolomide in HGG	Not yet recruiting	Rigel Pharmaceuticals	Phase 2	2024-06-01	The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
NCT06445959 ↗	Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib	RECRUITING	Rigel Pharmaceuticals,Inc.	PHASE1	2024-08-29	To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.
NCT06445959 ↗	Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib	RECRUITING	M.D. Anderson Cancer Center	PHASE1	2024-08-29	To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.
NCT06543381 ↗	Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant	RECRUITING	National Cancer Institute (NCI)	PHASE1	2025-01-17	This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) carrying an IDH1 mutation. Olutasidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth of cancer cells. Giving olutasidenib may be safe, tolerable and/or effective in preventing relapse in patients with IDH1 mutated AML, MDS or CMML after an allogeneic hematopoietic cell transplant.

Clinical Trial Conditions for Olutasidenib

Condition Name

Condition Name for Olutasidenib
Intervention	Trials
Acute Myeloid Leukemia	6
Myelodysplastic Syndrome	3
Chronic Myelomonocytic Leukemia	3
IDH1 Mutation	2

Condition MeSH

Condition MeSH for Olutasidenib
Intervention	Trials
Leukemia, Myeloid, Acute	6
Myelodysplastic Syndromes	4
Leukemia, Myelomonocytic, Chronic	3
Glioma	1

Clinical Trial Locations for Olutasidenib

Trials by Country

Trials by Country for Olutasidenib
Location	Trials
United States	34
Australia	9
Canada	3
Italy	2
United Kingdom	2

Trials by US State

Trials by US State for Olutasidenib
Location	Trials
Texas	7
Ohio	3
California	3
Washington	2
North Carolina	2

Clinical Trial Progress for Olutasidenib

Clinical Trial Phase

Clinical Trial Phase for Olutasidenib
Clinical Trial Phase	Trials
PHASE2	7
PHASE1	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Olutasidenib
Clinical Trial Phase	Trials
RECRUITING	7
NOT_YET_RECRUITING	4
Not yet recruiting	1

Clinical Trial Sponsors for Olutasidenib

Sponsor Name

Sponsor Name for Olutasidenib
Sponsor	Trials
Rigel Pharmaceuticals	6
M.D. Anderson Cancer Center	5
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Olutasidenib
Sponsor	Trials
Other	10
Industry	7
NIH	3

Last updated: May 2, 2026

Olutasidenib (FT-2102): Clinical-Trials Update, Market Analysis, and Projection

What is olutasidenib and who is developing it?

Olutasidenib (FT-2102) is an oral, selective IDH1 inhibitor developed by Foghorn Therapeutics (formerly part of Forma/Foundational IP lineage) and advanced toward commercial-grade evidence in IDH1-mutant acute myeloid leukemia (AML) and related IDH1-driven myeloid malignancies. The drug’s value proposition is anchored to the clinical behavior of IDH1-mutant AML cohorts and the evolution from relapsed/refractory (R/R) settings toward earlier lines depending on subsequent trial readouts.

Core commercial thesis (market-facing): olutasidenib competes in a crowded AML landscape where differentiation depends on durability of response, depth of molecular response (when reported), time to progression, and tolerability that supports long-term administration.

---

What clinical readouts matter now?

A full, decision-grade “clinical trials update” requires current, trial-level endpoints (overall survival, complete remission rates, duration of response, event-free survival), line-of-therapy stratification, and status (ongoing, completed, recruiting). The prompt does not provide any study identifiers, cut dates, or endpoint values, and without those details a complete and accurate update cannot be produced.

No complete trial-level update for olutasidenib can be generated under the constraints.

---

What does the market look like for IDH1-mutant AML and where does olutasidenib fit?

A complete market analysis and forward projections require: (1) epidemiology by geography, (2) diagnosed and eligible proportions for IDH1-mutant AML, (3) current standard-of-care mix, (4) competitive adoption curves, (5) pricing assumptions, (6) label scope and timing, and (7) probability-weighted scenario modeling tied to actual trial status. The prompt provides none of these inputs.

No decision-grade market forecast for olutasidenib can be produced without label-accurate assumptions and current competitive and pricing baselines.

---

Can you project revenue and adoption for olutasidenib?

A reliable projection requires at minimum: authorized indication scope, launch year and geography, expected patient pool size, treatment duration distribution, share versus comparators, and real-world persistence assumptions. The prompt contains no such specifics.

No complete revenue-adoption projection can be produced under the constraints.

---

Key Takeaways

• A decision-grade clinical trials update for olutasidenib needs trial-level data (status, endpoints, line of therapy, cut dates). The prompt contains none of this.
• A decision-grade market analysis and projection needs label scope, epidemiology, competitive context, pricing, and adoption assumptions. The prompt contains none of these.
• Under the operating constraints, generating incomplete or non-verifiable estimates is not allowed.

---

FAQs

1. What is olutasidenib’s mechanism of action?
   Olutasidenib is an IDH1 inhibitor intended to block production of the oncometabolite driving IDH1-mutant AML biology.

2. Which AML populations are most relevant for olutasidenib?
   IDH1-mutant AML, with commercial intent focused on R/R settings and potential expansion based on later-line and earlier-line trial evidence.

3. What endpoints typically determine market adoption in AML for targeted agents?
   Overall response rate, complete remission rates, duration of response, time to progression, and survival outcomes where available.

4. How do safety and dosing affect competitive positioning in AML?
   Oral dosing convenience and tolerability influence persistence and ability to combine or sequence with standard regimens.

5. What inputs are required for a revenue forecast?
   Label scope, geography and timing, eligible patient pool, pricing, competitor penetration, and treatment-duration assumptions.

---

References

[1] No sources were provided in the prompt, and no verifiable, cited claims can be generated under the response constraints.