Recruiting PHASE3 INTERVENTIONAL 8-arm NCT05303519

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) (SIGMA)

A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma

Sponsor: AnHeart Therapeutics Inc.

Conditions Astrocytoma, Grade IV Astrocytoma, IDH-Mutant, Grade 2 Astrocytoma, IDH-Mutant, Grade 3 Astrocytoma, IDH-Mutant, Grade 4 Glioma IDH1-mutant Glioma Oligodendroglioma Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted

Interventions Placebo safusidenib

Updated 16 times since 2022 Last updated: Mar 3, 2026 Started: Jun 5, 2023 Primary completion: Dec 1, 2028 Completion: Dec 1, 2030

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05303519, this PHASE3 trial focuses on Astrocytoma, Grade IV and Astrocytoma, IDH-Mutant, Grade 2 and remains actively recruiting participants. Sponsored by AnHeart Therapeutics Inc., it has been updated 16 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

16 versions recorded

Mar 2026 — Present [monthly]

Recruiting PHASE3
Feb 2026 — Mar 2026 [monthly]

Recruiting PHASE3

Phase: PHASE2 → PHASE3
Jan 2026 — Feb 2026 [monthly]

Recruiting PHASE2
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE2
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE2

▶ Show 11 earlier versions

Sep 2025 — Nov 2025 [monthly]

Recruiting PHASE2
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE2
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE2

Status: Active Not Recruiting → Recruiting
Jun 2025 — Jul 2025 [monthly]

Active Not Recruiting PHASE2
Dec 2024 — Jun 2025 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
Sep 2024 — Dec 2024 [monthly]

Recruiting PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE2
Dec 2023 — Jul 2024 [monthly]

Recruiting PHASE2
Jun 2023 — Dec 2023 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
May 2022 — Jun 2023 [monthly]

Not Yet Recruiting PHASE2
Apr 2022 — May 2022 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AnHeart Therapeutics Inc.
Nuvation Bio Inc.

Data source: Nuvation Bio Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aurora, United States , Beijing, China , Birmingham, United States , Boston, United States , Changsha, China , Charlottesville, United States , Chengdu, China , Cleveland, United States , Dallas, United States , Darlinghurst, Australia and 27 more locations