Senaparib is a synthetic small-molecule anticancer active pharmaceutical ingredient belonging to the poly(ADP-ribose) polymerase (PARP) inhibitor class. It is an orally active, selective inhibitor of PARP1 and PARP2 and has been developed for oncology applications involving tumors with defects in DNA repair pathways. Senaparib is also known by the development code IMP4297 or IMP-4297.
The free active moiety of Senaparib is identified by CAS Number 1401682-78-7 and has the molecular formula C24H20F2N6O3 with a molecular weight of approximately 478.45 g/mol. The approved Chinese pharmaceutical product contains Senaparib in its dihydrate form, represented as C24H20F2N6O3·2H2O with a molecular weight of 514.48 g/mol. This distinction is important when preparing API specifications and calculating assay on an active-moiety basis.
Senaparib has a quinazolinedione-based chemical structure containing fluorinated aromatic groups, a piperazine-pyrimidine moiety and a methyl-free active structure. It is an achiral molecule with no defined stereocenters. FDA GSRS identifies Senaparib as the active moiety and separately identifies Senaparib Hydrochloride as a 1:1 hydrochloride salt.
The pharmaceutical development code IMP4297 is widely used in scientific and manufacturing literature. Senaparib has also been designated JS109 in development programs. Its mechanism is based on inhibition of PARP1 and PARP2, enzymes involved in the repair of single-strand DNA damage. PARP inhibition can result in accumulation of DNA damage and increased tumor-cell death, particularly in tumors with impaired homologous recombination repair.
Senaparib is an oncology API developed for maintenance treatment in advanced ovarian cancer and related gynecologic malignancies. The Chinese product information approved in January 2025 describes Senaparib capsules for maintenance treatment of adults with advanced epithelial ovarian cancer, fallopian-tube cancer or primary peritoneal cancer following a complete or partial response to first-line platinum-containing chemotherapy.
Senaparib is therefore an important pharmaceutical ingredient for oncology formulations and research involving PARP inhibition, DNA-damage response and synthetic-lethality mechanisms.
Senaparib free base has the molecular formula C24H20F2N6O3 and molecular weight 478.45 g/mol. PubChem reports an exact mass of 478.1565 Da, XlogP3 of approximately 2.0, eight hydrogen-bond acceptors, one hydrogen-bond donor and a topological polar surface area of 98.7 Ų.
The approved pharmaceutical material is the dihydrate form. The Chinese prescribing information specifies C24H20F2N6O3·2H2O and a molecular weight of 514.48. The capsule contents are described as white to off-white powder.
Senaparib is a synthetic small-molecule API and can be characterized using conventional pharmaceutical analytical techniques. Identity can be confirmed by infrared spectroscopy, HPLC retention characteristics, NMR and mass spectrometry. HPLC is suitable for assay and related-substance evaluation, while chromatographic methods can be used to control process-related and degradation impurities.
Commercial analytical reference materials report very high HPLC purity, including selected batches at 99.98%, but these values represent individual commercial batches and should not be presented as a universal pharmacopoeial specification.
Because Senaparib is supplied in hydrated pharmaceutical form, water or hydrate-state control is also important. The specific specification should distinguish between active-moiety assay and the dihydrate form to avoid incorrect molecular-weight calculations.
Pharmaceutical-grade Senaparib should be manufactured under controlled synthetic processes with appropriate control of starting materials, intermediates, related substances, residual solvents, solid form and final API purity. A suitable technical package can include Certificate of Analysis, HPLC assay and impurity profile, identity data, residual-solvent results, water or hydrate-state information and stability documentation.
Senaparib should be packaged in suitable pharmaceutical containers that protect the API from moisture, contamination and environmental degradation. The storage condition should be established from the validated stability data of the specific API form. Hydrated and anhydrous forms should not be interchanged without appropriate solid-state and stability evaluation.
Documentation for Senaparib API may include Certificate of Analysis, specification sheet, analytical methods, impurity profile, residual-solvent data, water-content or hydrate characterization, stability information and applicable GMP or regulatory documentation.
Senaparib is a structurally distinct PARP1/2 inhibitor with an established oncology development and regulatory history. Its quality assessment requires accurate control of chemical identity, assay, related substances, residual solvents and the correct solid-state form. Correctly distinguishing Senaparib free active moiety, Senaparib dihydrate and Senaparib hydrochloride is essential for pharmaceutical API documentation and manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 99.0% |