Drugs / NUV-422
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | high-grade glioma, breast cancer, prostate cancer | 2022-06-27 | “The FDA verbally placed a partial clinical hold on the Phase 1 dose escalation portion of the Company’s NUV-422-02 study in June 2022.” nuvationbio.com ↗ “FDA has placed a partial clinical hold on the Company’s Phase 1 dose escalation study of NUV-422 in solid tumors” nuvationbio.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04541225 | Dec 2020 → Aug 2022 | breast carcinoma, castration-resistant prostate carcinoma, glioblastoma, mixed glioma | Nuvation Bio Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05191004 | Sep 2022 → Jun 2025 | breast carcinoma | Nuvation Bio Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05191017 | Sep 2022 → Jan 2025 | prostate carcinoma | Nuvation Bio Inc. | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-06-27 | Nuvation Bio Inc. | Regulatory Nuvation Bio Announces FDA Partial Clinical Hold for Phase 1 Study of NUV-422 in Solid Tumors nuvationbio.com ↗
While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-08-01 | Nuvation Bio Inc. | Nuvation Bio Announces Discontinuation of NUV-422 Clinical Development Program nuvationbio.com ↗ |
| 2022-06-27 | Nuvation Bio Inc. | Nuvation Bio Announces FDA Partial Clinical Hold for Phase 1 Study of NUV-422 in Solid Tumors nuvationbio.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NUV-422 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05191004 ↗ |
| Route | Oral | “self-administered NUV-422 orally” NCT04541225 ↗ |