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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Protagonist Therapeutics, Inc. | PTGX | 2 | PHASE3 | Rusfertide |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-3405 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
PRT12396 is an investigational small molecule being developed for Polycythemia Vera (PV), a type of myeloproliferative neoplasm. It is also being studied in related conditions including Myelofibrosis (MF), Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis, and Post-Essential Thrombocythemia Myelofibrosis. The drug is currently in Phase 1 clinical development.
PRT12396 targets the JAK2V617F mutation, a specific kinase mutation associated with myeloproliferative neoplasms. As a kinase inhibitor, it is designed to interfere with the signaling pathway driven by this mutated enzyme. The drug is being evaluated in patients with Polycythemia Vera and other myeloproliferative neoplasms.
PRT12396 is being developed by Prelude Therapeutics Incorporated, a biopharmaceutical company traded under the ticker symbol PRLD. The company is conducting a Phase 1 clinical trial of PRT12396 in patients with select myeloproliferative neoplasms, including Polycythemia Vera and Myelofibrosis.
PRT12396 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is currently recruiting participants to evaluate the safety, tolerability, and preliminary efficacy of PRT12396 in patients with myeloproliferative neoplasms.
PRT12396 is being studied in a single Phase 1 clinical trial registered as NCT07469891. This open-label, controlled study is recruiting approximately 100 participants aged 18 years and older with Polycythemia Vera, Myelofibrosis, or other myeloproliferative neoplasms. The trial is being conducted in the United States and Spain.
PRT12396 is the primary identifier for this investigational compound. No alternative names or brand names have been associated with PRT12396 in the available clinical trial information. It is being studied under this designation by Prelude Therapeutics in its Phase 1 program for myeloproliferative neoplasms.