Crinecerfont is a selective corticotropin-releasing factor type 1 (CRF1) receptor antagonist and a pharmaceutical active ingredient used in the treatment of congenital adrenal hyperplasia (CAH). By blocking CRF1 receptors, crinecerfont reduces excessive adrenocorticotropic hormone (ACTH) secretion and helps reduce adrenal androgen production.
Crinecerfont is a synthetic small-molecule active pharmaceutical ingredient. It is the free-base form used in the approved pharmaceutical product Crenessity. Crinecerfont is identified by CAS No. 752253-39-7, with molecular formula C₂₇H₂₈ClFN₂OS and molecular weight 483.04 g/mol.
Crinecerfont is also known by the development codes NBI-74788 and SSR-125543.
Crinecerfont selectively antagonizes the CRF1 receptor, reducing CRF-mediated stimulation of ACTH secretion from the pituitary. Reduced ACTH stimulation decreases adrenal androgen production and can support optimization of glucocorticoid replacement in patients with congenital adrenal hyperplasia.
Crinecerfont is used as an adjunct to glucocorticoid replacement therapy in patients with congenital adrenal hyperplasia (CAH). The FDA approved Crenessity (crinecerfont) in December 2024 for adults and pediatric patients aged 4 years and older with CAH.
Crinecerfont API can be supplied for pharmaceutical research, development, formulation and manufacturing applications, subject to applicable quality and regulatory requirements.
Quality evaluation may include identity, assay, related substances, residual solvents, water content, residue on ignition, elemental impurities and other applicable pharmaceutical quality attributes.
Final acceptance criteria should always be based on the approved product specification, validated analytical methods and batch-specific Certificate of Analysis (CoA).
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to Crinecerfont identity by validated analytical methods such as HPLC, LC-MS and/or IR |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |
| Solubility | Less than 0.01 mg/mL in aqueous medium |