Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRT12396 · 1 trial · 6 indications
Incidence of dose limiting toxicities, defined according to protocol-specified criteria
Incidence and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0
Incidence of AEs leading to dose reductions, dose interruptions, treatment discontinuations, and clinically significant laboratory abnormalities
Determination of the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]) based on evaluation of DLTs, safety, and tolerability data
| Arm | Type | Description |
|---|---|---|
| PRT12396: MF | EXPERIMENTAL | Participants with myelofibrosis receive PRT12396, an investigational oral capsule, administered twice daily. The study includes a dose-escalation followed by dose-expansion at the recommended dose for expansion (RDE) |
| PRT12396: PV | EXPERIMENTAL | Participants with polycythemia vera receive PRT12396, an investigational oral capsule, administered twice daily. The study includes a dose-escalation followed by dose-expansion at the recommended dose for expansion (RDE) |
| Name | Type | Description |
|---|---|---|
| PRT12396 | DRUG | PRT12396 is an investigational oral capsule administered twice daily at the assigned dose level or RDE. Capsules are swallowed whole with water and may be taken one hour before or two hours after meals. |
Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures. * Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC/WHO 2022 criteria * Docum...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Bomedemstat |
| Protagonist Therapeutics, Inc. | PTGX | 2 | PHASE3 | Rusfertide |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-3405 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE2 | Rusfertide |
| Agios Pharmaceuticals, Inc. | AGIO | 1 | PHASE2 | AG-236 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
PRT12396 is an investigational small molecule being developed by Prelude Therapeutics Incorporated for polycythemia vera, a myeloproliferative neoplasm. It is in Phase 1 clinical development and is designed to target the JAK2V617F mutation. It has not been approved by the FDA and remains under study.
PRT12396 is being studied for the treatment of polycythemia vera, a myeloproliferative neoplasm. The Phase 1 trial also enrolls participants with related conditions, including myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis, and primary myelofibrosis. PRT12396 is investigational and has not been approved for any indication.
PRT12396 targets JAK2V617F, a mutant form of the JAK2 kinase. JAK2V617F is a driver mutation in myeloproliferative neoplasms such as polycythemia vera. PRT12396 is a small molecule kinase inhibitor designed to act on this target, and the Phase 1 study is biomarker selected for participants with this mutation.
PRT12396 is being developed by Prelude Therapeutics Incorporated, which trades on the Nasdaq under the ticker PRLD. Prelude Therapeutics is the sponsor of the Phase 1 clinical study evaluating PRT12396 in myeloproliferative neoplasms.
PRT12396 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial is currently recruiting participants and has an estimated enrollment of 100. No trials of PRT12396 have been completed.
PRT12396 is being evaluated in one Phase 1 trial, NCT07469891, titled A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms. The trial is recruiting, has an estimated enrollment of 100 participants, and is conducted in the United States, Australia, France, and Spain. It enrolls adults 18 years and older.