COMPANY
Nuvation Bio Inc.
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start Phase 2: Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease source ↗
- Trial start Phase 3: Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma source ↗
- FDA FDA New indication / efficacy supplement: IBTROZI (taletrectinib adipate) — NDA219713/4, Sep 16, 2026. Applicant at approval: Nuvation Bio Inc. source ↗
- Trial start Phase 1: Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib source ↗
- Debt Debt: $250M (not counted as a raise), announced Jun 25, 2026. Source: SEC filing. source ↗
- Partnership Partnership / licensing: $230M (upfront, as published), announced Jan 12, 2026. Source: SEC filing. source ↗
- Trial start 3: Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) source ↗
- FDA FDA New drug/biologic (novel): IBTROZI (taletrectinib adipate) — NDA219713, Jun 11, 2025. Applicant at approval: Nuvation Bio Inc. source ↗
- Trial start III: A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients source ↗
- Trial start Phase 1/Phase 2: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors source ↗
- Trial start Phase 3: SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) source ↗
- Trial start Phase 1: Study the Effect of Omeprazole on AB-106 Pharmacokinetics source ↗
- Trial start Phase 1/Phase 2: Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC source ↗
- Trial start Phase 1/Phase 2: Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC source ↗
- Trial start Phase 1: NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors source ↗
- Trial start 2: Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC source ↗
- Trial start Phase 1: A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK source ↗
- Trial start Phase 1: A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin source ↗
- Trial start II: Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene Fusion source ↗
- Trial start Phase 1: Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors source ↗
- Trial start Phase 2: A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene source ↗
- Trial start Phase 1: A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b source ↗
Upcoming milestones
- Feb 2, 2027 (ESTIMATED) · Phase 1 · Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib · NCT07742384
- 2027-03 (ESTIMATED) · Phase 1/Phase 2 · Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors · NCT06334432
- Dec 1, 2028 (ESTIMATED) · Phase 3 · SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) · NCT05303519
- 2029-01 (ESTIMATED) · III · A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients · NCT06564324
- 2029-05 (ESTIMATED) · Phase 3 · Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma · NCT07712757
- Aug 30, 2030 (ESTIMATED) · 3 · Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) · NCT07154706
- 2030-09 (ESTIMATED) · Phase 2 · Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease · NCT07703436
Funding
Clinical trials (lead sponsor) 19
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07703436 | Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease | Phase 2 | Not yet recruiting | 2027-03 | 2030-09 (estimated) |
| NCT05303519 | SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) | Phase 3 | Recruiting | Jun 5, 2023 | Dec 1, 2028 (estimated) |
| NCT07742384 | Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib | Phase 1 | Not yet recruiting | Aug 1, 2026 | Feb 2, 2027 (estimated) |
| NCT07712757 | Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma | Phase 3 | Not yet recruiting | 2027-03 | 2029-05 (estimated) |
| NCT07154706 | Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) | 3 | Recruiting | Aug 21, 2025 | Aug 30, 2030 (estimated) |
| NCT06564324 | A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients | III | Recruiting | Nov 27, 2024 | 2029-01 (estimated) |
| NCT04395677 | A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene | Phase 2 | Active, not recruiting | Jul 7, 2020 | Jun 7, 2024 (actual) |
| NCT04617054 | Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene Fusion | II | Terminated | Jun 1, 2021 | Dec 6, 2024 (actual) |
| NCT06334432 | Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors | Phase 1/Phase 2 | Active, not recruiting | Mar 14, 2024 | 2027-03 (estimated) |
| NCT04919811 | Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC | 2 | Active, not recruiting | Sep 1, 2021 | Jun 11, 2025 (actual) |
| NCT06841874 | Expanded Access Program of Taletrectinib in Patients With Advanced or Metastatic ROS1-Positive NSCLC | Not listed | No longer available | Not listed | Not listed |
| NCT05252390 | NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors | Phase 1 | Terminated | Mar 29, 2022 | Jul 15, 2024 (actual) |
| NCT02279433 | A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b | Phase 1 | Completed | 2014-09 | 2019-03 (actual) |
| NCT05357911 | A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin | Phase 1 | Completed | Jul 13, 2021 | Aug 20, 2021 (actual) |
| NCT05609929 | Study the Effect of Omeprazole on AB-106 Pharmacokinetics | Phase 1 | Completed | Nov 2, 2022 | Jan 20, 2023 (actual) |
| NCT05357820 | A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK | Phase 1 | Completed | Jul 19, 2021 | Dec 3, 2021 (actual) |
| NCT04541225 | Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors | Phase 1 | Terminated | Dec 8, 2020 | Aug 31, 2022 (actual) |
| NCT05191004 | Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC | Phase 1/Phase 2 | Withdrawn | 2022-09 | 2025-06 (estimated) |
| NCT05191017 | Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC | Phase 1/Phase 2 | Withdrawn | 2022-09 | 2025-01 (estimated) |
FDA records (last 2 years)
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