N-[5-(2-METHOXY-6-METHYLPYRIDIN-3-YL)-1H-PYRAZOL-3-YL]-6-[(3R)-PIPERIDIN-3-YL]OXYPYRAZIN-2-AMINE

Table of contents

• What is this substance?
• How does it work?
• Which conditions is it studied for?
• How is it given?
• What do the clinical trials show?
• What side effects are known?

What is this substance?

N-[5-(2-METHOXY-6-METHYLPYRIDIN-3-YL)-1H-PYRAZOL-3-YL]-6-[(3R)-PIPERIDIN-3-YL]OXYPYRAZIN-2-AMINE, is a chemically synthesised substance of chemical origin. It is classified under the therapeutic area of neoplasms (cancers) and is supplied by Esperas Pharma, Inc. In the product records of the clinical trial, it has no marketing authorisation, meaning it is an investigational substance still being studied rather than an authorised medicine.^[1]

How does it work?

The registry data and the trial record do not describe the molecular target or mechanism of action of this substance. The trial summary indicates that the study assessed the safety and tolerability of the substance in combination with gemcitabine in patients with BRCA1/2 wildtype high-grade serous ovarian cancer, but no further pharmacological detail is provided in the available sources.^[1]

Which conditions is it studied for?

• Advanced or metastatic cancer — the trial enrolled patients with advanced or metastatic cancer, a broad category of cancers that have spread beyond the original site.
• BRCA1/2 wildtype high-grade serous ovarian cancer (HGSOC) — the brief summary specifically mentions patients with BRCA1/2 wildtype HGSOC, a form of ovarian cancer without BRCA gene mutations.

How is it given?

The substance is formulated as capsules and is given by the oral route, meaning it is taken by mouth. In the trial, a dose of 100 mg orally was reported for the substance, while gemcitabine was given intravenously at 100 mg/m².^[1]

What do the clinical trials show?

One completed Phase 2 trial (EU CT number 2023-503459-91-00) investigated this substance in 25 patients with advanced or metastatic cancer. The trial was interventional and focused on safety and tolerability when the substance was combined with gemcitabine. The primary outcome was safety, measured as treatment-emergent adverse events, serious adverse events, and clinical abnormalities according to the Common Terminology Criteria for Adverse Events. The trial specifically included patients with BRCA1/2 wildtype high-grade serous ovarian cancer.^[1]

The trial status is completed, meaning the study has finished. No efficacy results are reported in the registry record; the primary focus was safety and tolerability rather than measuring how well the treatment works.^[1]

What side effects are known?

No side effect data are available in the provided sources. The trial measured treatment-emergent adverse events and serious adverse events as its primary outcome, but the results are not reported in the registry record.^[1]