Drugs / Unesbulin
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03761095 | Mar 2019 → Feb 2024 | leiomyosarcoma | PTC Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03605550 | Aug 2018 → Mar 2024 overdue | diffuse intrinsic pontine glioma, high grade astrocytic tumor | Nationwide Children's Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03206645 | Aug 2017 → Aug 2021 | ovarian cancer | University of Oklahoma | Completed | No outcome recorded |
| Phase 1 | NCT02404480 | Jan 2016 → Feb 2017 | cancer | PTC Therapeutics | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05269355 | May 2022 → Jun 2024 | leiomyosarcoma | PTC Therapeutics | Terminated | Met primary Stop: Business |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-06-03 | PTC Therapeutics | Results Preliminary Results Presented at ASCO Demonstrated Promising Clinical Efficacy with Unesbulin in Leiomyosarcoma Study ptcbio.com ↗
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced encouraging preliminary safety and efficacy results from its Phase 1B study of unesbulin (PTC596) in advanced leiomyosarcoma (LMS) patients. |
| 2020-11-18 | PTC Therapeutics | Regulatory PTC Therapeutics Announces Key Regulatory Designations for PTC596 to Advance Treatment of Two Rare Oncology Indications ptcbio.com ↗
Furthermore, the FDA has also granted PTC596 a Rare Pediatric Disease designation and Orphan Drug Designation for the potential treatment of Diffuse Intrinsic Pontine Glioma (DIPG), an ultra-rare childhood glioma. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-03 | PTC Therapeutics | Preliminary Results Presented at ASCO Demonstrated Promising Clinical Efficacy with Unesbulin in Leiomyosarcoma Study ptcbio.com ↗ |
| 2020-11-18 | PTC Therapeutics | PTC Therapeutics Announces Key Regulatory Designations for PTC596 to Advance Treatment of Two Rare Oncology Indications ptcbio.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Unesbulin | “The goal of this study is to evaluate the safety of the study drug PTC596 (Unesbulin) taken in combination with radiotherapy (RT) when given to pediatric patients newly...” NCT03605550 ↗ |
| Known as | Bmi1 inhibitor ptc596 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594353 ↗ |
| Known as | PTC596 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02404480 ↗ |
| Action | Inhibit | “To test the ability of PTC596 to inhibit BMI-1 activity in tumor and PBMCs” NCT03605550 ↗ |
| Modality | Small molecule | — CHEMBL4594353 ↗ |
| Route | Oral | “administered orally” NCT02404480 ↗ |
| Target | BMI1 | “To test the ability of PTC596 to inhibit BMI-1 activity in tumor and PBMCs” NCT03605550 ↗ |