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Elenestinib · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| (Part 1) Elenestinib Dose 1 + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily until completion of Part 1. |
| (Part 1) Elenestinib Dose 2 + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily until completion of Part 1. |
| (Part 1) Elenestinib Dose 3 + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily until completion of Part 1. |
| (Part 1) Placebo + SDT | PLACEBO_COMPARATOR | Participants will receive SDT and matching placebo. SDT will be determined on a per participant basis. Placebo will be administered orally, once daily until completion of Part 1. |
| (Part 2) Elenestinib Dose 1 + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily for approximately 48 weeks. |
| (Part 2) Placebo + SDT | PLACEBO_COMPARATOR | Participants will receive SDT and matching placebo. SDT will be determined on a per participant basis. Placebo will be administered orally, once daily for approximately 48 weeks. |
| (Part 3) Elenestinib + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily for up to approximately 5 years. |
| (Part S) Elenestinib Dose 1 + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily for up to approximately 5 years. |
| (Part K) Elenestinib Dose 1 + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily for up to approximately 5 years. |
| (PK groups) Elenestinib + SDT | EXPERIMENTAL | Participants will receive SDT and elenestinib. SDT will be determined on a per participant basis. Elenestinib will be administered orally, once daily for up to approximately 5 years. |
| Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Elenestinib | DRUG | Elenestinib oral tablet |
| Placebo | DRUG | Placebo oral tablet |
| Midazolam | DRUG | Specified dose on specified days |
| Levonorgestrel/Ethinyl Estradiol | DRUG | Specified dose on specified days |
Key Inclusion Criteria: All Participants: -Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2. Part 1 and PK groups: * Participant has confirmed diagnosis of ISM, confirmed by Central Pathology Review * Participant must have failed to achieve adequ...
Elenestinib is an investigational small molecule being studied for indolent systemic mastocytosis and smoldering systemic mastocytosis, as well as in healthy participants. It is being developed by Blueprint Medicines Corporation (BPMC) and is currently in Phase 1 clinical development.
Elenestinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is designed to target kinases, which are enzymes involved in cellular signaling. The specific molecular target is not disclosed in the available information.
Elenestinib is being developed by Blueprint Medicines Corporation, a biopharmaceutical company traded on the stock exchange under the ticker symbol BPMC. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Elenestinib is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety, tolerability, and potential efficacy in the studied conditions.
Elenestinib is being studied in two clinical trials. NCT04910685 is a Phase 2 study in patients with indolent or smoldering systemic mastocytosis, currently recruiting. NCT07388511 is a Phase 1 study in healthy adult female participants, which has been completed.
Elenestinib is also known as BLU-263. The Phase 2 trial NCT04910685, titled 'HARBOR Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis', confirms that BLU-263 is the same drug as Elenestinib.