Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'2118, a Corticotropin-Releasing Factor Type 2 Receptor Agonist

• NBIP-'2118 targets a new, non-incretin mechanism for weight loss with lean mass preservation

SAN DIEGO, May 4, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'2118 in adult participants. NBIP-'2118 is an investigational corticotropin-releasing factor type 2 receptor (CRF₂) peptide agonist and a potential first-in-class therapy for obesity.

"This program represents an important step in applying Neurocrine's expertise in CRF biology to treat metabolic disease," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "CRF₂ agonism is a promising and differentiated mechanism with the potential to address key limitations of existing therapies, including the loss of lean mass during weight reduction. We believe this program could play a meaningful role as both a standalone therapy and in combination with other mechanisms, including incretin-based approaches."

The Phase 1 study initially will evaluate the safety and tolerability of single ascending doses of NBIP-'2118 compared to placebo in healthy-weight adult participants, as well as those who are overweight or obese. Initial data is expected in 2027.

NBIP-'2118 is an internally discovered and investigational CRF₂ peptide agonist designed for once-weekly subcutaneous administration. In preclinical models, NBIP-'2118 demonstrated high selectivity and potency, with weight loss primarily driven by fat reduction while preserving or increasing lean mass, including skeletal muscle. By targeting CRF₂ to both reduce fat and preserve muscle, NBIP-'2118 could be particularly beneficial for patients at risk of muscle loss with a differentiated profile from existing therapies which often attribute a significant proportion of weight loss to lean mass.

Neurocrine's integrated obesity strategy includes multiple programs in preclinical development. NBIP-'1968 is an internally discovered, investigational triple agonist targeting GLP-1, GIP, and glucagon receptors and is intended for use in combination with NBIP-'2118, with the goal of achieving greater weight loss while maintaining muscle-sparing benefits. Neurocrine is also advancing a single-molecule incretin mimetic-CRF₂ agonist conjugate. In addition, Neurocrine is developing a long-acting triple-agonist (targeting GLP-1, GIP, glucagon receptors) conjugated to an antibody Fc domain to extend half-life and potentially enable once-monthly or even less frequent dosing.

About Obesity
Obesity is a chronic disease characterized by excess body fat and is associated with serious health conditions, including type 2 diabetes, cardiovascular disease and certain cancers. It is driven by complex biological, environmental, and genetic factors – not simply lifestyle or willpower. Obesity has reached epidemic levels globally, affecting a significant portion of adults and placing a substantial burden on public health systems. Despite recent advances in treatment, there remains a need for additional therapies that support safe, effective and sustainable long-term weight management.

About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading 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, endocrine, psychiatric, and immunological 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, Facebook and YouTube. (*in collaboration with AbbVie)

NEUROCRINE, the NEUROCRINE BIOSCIENCES logo and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.

Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the efficacy and therapeutic potential of NBIP-'2118, NBIP-'1968 and other preclinical programs for obesity. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing and commercialization activities for our products and product candidates and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.

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SOURCE Neurocrine Biosciences, Inc.