Neurocrine Biosciences Announces initiation of Phase 1 Clinical trial Evaluating NBIP-01435

Neurocrine Biosciences Announces initiation of Phase 1 Clinical trial Evaluating NBIP-01435

By, Admin 1 July 2025

Overview

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of investigational compound NBIP-01435 in healthy adult participants. NBIP-01435 is a long-acting corticotropin-releasing factor type 1 receptor antagonist administered as a subcutaneous injection for the potential treatment of congenital adrenal hyperplasia (CAH).

Words from Sanjay Keswani: Chief Medical Officer, Neurocrine Biosciences

As a leader in CAH, Neurocrine is dedicated to expanding treatment options for patients with congenital adrenal hyperplasia,"" said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. ""This is the first investigational peptide from our biologics pipeline to proceed to the clinic, and we look forward to seeing the potential of these molecules and how they can complement our robust small molecule portfolio.

About the condition: congenital adrenal hyperplasia

  • CAH is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. 
  • The deficiency of cortisol, an essential hormone for life, results in the production of excess adrenal androgens, which has typically been treated with supraphysiologic doses of glucocorticoids.

About NBIP-01435

  • NBIP-01435 is an investigational long-acting corticotropin-releasing factor type 1 receptor (CRF1) antagonist. 
  • CRF1 antagonism has been shown to improve androgen control and allow for lower, more physiological glucocorticoid dosing regimens for patients with CAH. 
  • In December 2024, Neurocrine received FDA approval for crinecerfont, an oral CRF1 antagonist, the first new treatment in 70 years for CAH.  

In April 2021, Neurocrine entered into a research collaboration with Sentia Medical Sciences, Inc., for the discovery of novel peptide CRF receptor antagonists, including NBIP-01435, for which Neurocrine has exclusive rights to develop and commercialize.

About Neurocrine Biosciences, Inc.  

  • Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. 
  • We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. 
  • The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. 
  • For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. 
  • We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
  • NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.

Forward-Looking Statements

  • This press release includes forward-looking statements related to the efficacy and therapeutic potential of NBIP-01435, beyond historical facts.
  • These statements are subject to numerous risks and uncertainties, which could result in material differences between projected and actual outcomes.

Key risk factors include:

Delays or failures in clinical development, regulatory approvals, or manufacturing
Inability to replicate past trial results or translate findings to real-world settings
Adverse decisions by the FDA or other regulatory authorities
Challenges in regulatory submissions or commercialization

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