Neurocrine Biosciences Begins Phase 1 Trial for NBIP-01435, a Long-Acting CRF1 Receptor Antagonist

SAN DIEGO, June 30, 2025 – Neurocrine Biosciences, Inc. has commenced a Phase 1 clinical trial to assess various aspects, including safety and tolerability, of NBIP-01435 in healthy adults. This investigational drug is a long-acting corticotropin-releasing factor type 1 receptor antagonist, potentially useful in treating congenital adrenal hyperplasia (CAH) when administered via subcutaneous injection.

Sanjay Keswani, M.D., the company's Chief Medical Officer, emphasized Neurocrine's commitment to broadening treatment possibilities for CAH, a rare genetic disorder characterized by enzyme deficiencies that affect adrenal hormone production. This condition usually leads to an overproduction of adrenal androgens due to a cortisol deficiency, which is traditionally managed with high doses of glucocorticoids.

NBIP-01435 is designed to manage androgen levels and enable more physiologically appropriate glucocorticoid dosing. Neurocrine's success with crinecerfont, an oral CRF1 antagonist approved by the FDA in December 2024, marked the first new CAH treatment in seven decades. Neurocrine's partnership with Sentia Medical Sciences, Inc., initiated in April 2021, focuses on creating novel peptide CRF receptor antagonists, including NBIP-01435, with Neurocrine holding exclusive development and commercialization rights.

Neurocrine Biosciences is renowned for its dedication to alleviating suffering in people with significant healthcare needs, focusing on developing groundbreaking treatments for neurological, neuroendocrine, and neuropsychiatric disorders. Their portfolio includes FDA-approved therapies for conditions such as tardive dyskinesia, Huntington's disease-related chorea, and CAH. Additionally, Neurocrine is advancing a pipeline with multiple candidates in various stages of clinical development.

For over 30 years, the company has leveraged its expertise in neuroscience and the intricate connections between brain and body systems to address complex medical conditions. Neurocrine remains committed to advancing brave science to ease the burden of challenging diseases, with the aim of delivering transformative therapies to those who need them most.