Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'2118, a Corticotropin-Releasing Factor Type 2 Receptor Agonist
Rhea-AI Summary
Neurocrine Biosciences (Nasdaq: NBIX) initiated a Phase 1 first-in-human study of NBIP-'2118, a CRF2 peptide agonist for obesity, on May 4, 2026. The trial will test single ascending doses versus placebo in healthy-weight, overweight, and obese adults, with initial data expected in 2027.
NBIP-'2118 is designed for once-weekly subcutaneous dosing; preclinical data showed fat loss with preservation or increase of lean mass. Neurocrine is developing complementary programs including NBIP-'1968 (GLP-1/GIP/glucagon triple agonist) and CRF2-incretin conjugates.
Positive
- Phase 1 first-in-human study of NBIP-'2118 initiated (May 4, 2026)
- Preclinical results show fat loss with preservation or increase of lean mass
- NBIP-'2118 designed for once-weekly subcutaneous dosing
- Integrated obesity strategy includes NBIP-'1968 triple-agonist for combination use
Negative
- No human safety or efficacy data yet; initial clinical data expected in 2027
- Program remains early-stage (Phase 1), clinical and regulatory risks remain
News Market Reaction – NBIX
In the May 4 session, NBIX gained 1.74%, reflecting a mild positive market reaction. Argus tracked a peak move of +5.0% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jan 26 | Phase 2 TD initiation | Positive | -1.2% | Launched Phase 2 study of NBI-1065890 for tardive dyskinesia. |
| Dec 22 | Phase 3 DCP miss | Negative | -0.2% | Valbenazine Phase 3 in dyskinetic cerebral palsy failed primary and key endpoints. |
| Nov 10 | Phase 2 MDD miss | Negative | -1.8% | NBI-1070770 Phase 2 in MDD did not meet primary endpoint vs placebo. |
| Sep 22 | Positive Phase 2 MDD | Positive | +1.0% | Osavampator Phase 2 showed statistically significant depression improvements. |
| Jul 14 | CAHtalyst weight data | Positive | -2.9% | Phase 3 CAHtalyst data showed improved weight-related outcomes in CAH. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial news has often led to modest downside, especially when studies miss endpoints, though positive data sometimes aligns with gains.
Over the past year, Neurocrine has issued multiple clinical trial updates across CNS and endocrine programs. A Jan 26, 2026 Phase 2 TD initiation saw a -1.23% move, while a Sep 22, 2025 positive MDD Phase 2 readout aligned with a 0.96% gain. Negative outcomes, such as the Nov 10, 2025 MDD Phase 2 miss and the Dec 22, 2025 valbenazine Phase 3 miss, coincided with declines. Today’s Phase 1 obesity study fits this pattern of pipeline diversification via clinical milestones.
Key Terms
corticotropin-releasing factor type 2 receptor medical
peptide agonist medical
subcutaneous medical
glp-1 medical
gip medical
fc domain medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- NBIP-'2118 targets a new, non-incretin mechanism for weight loss with lean mass preservation
"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
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SOURCE Neurocrine Biosciences, Inc.