STOCK TITAN

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

(Neutral)

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.

Loading...
Loading translation...

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

+1.74%
4 alerts
+1.74% Session close to close
+5.0% Peak Tracked
$13.58B Market Cap
0.0x Rel. Volume

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.

Market Context

This announcement adds a first-in-human Phase 1 study of NBIP-'2118, a CRF2 peptide agonist targetin...
Analysis

This announcement adds a first-in-human Phase 1 study of NBIP-'2118, a CRF2 peptide agonist targeting obesity with a non-incretin, once-weekly approach and a focus on preserving lean mass. It fits into a broader obesity strategy that includes triple-agonist and conjugate programs. Historically, NBIX clinical-trial news has produced mixed market reactions, so investors may watch future readouts around 2027 and how this asset complements existing endocrine and CNS franchises.

Key Figures

Study phase: Phase 1 Dose design: Single ascending doses Initial data timing: 2027 +2 more
5 metrics
Study phase Phase 1 First-in-human NBIP-'2118 obesity study
Dose design Single ascending doses NBIP-'2118 vs placebo in adults
Initial data timing 2027 First readout expected from Phase 1 study
Dosing frequency Once-weekly Subcutaneous administration of NBIP-'2118
Target receptors GLP-1, GIP, glucagon Triple-agonist NBIP-'1968 and long-acting Fc program

Previous Clinical trial Reports

5 past events · Latest: Jan 26 (Positive)
Same Type Pattern 5 events
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.

Pattern Detected

Clinical trial news has often led to modest downside, especially when studies miss endpoints, though positive data sometimes aligns with gains.

Recent Company History

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, peptide agonist, subcutaneous, glp-1, +2 more
6 terms
corticotropin-releasing factor type 2 receptor medical
"NBIP-'2118 is an investigational corticotropin-releasing factor type 2 receptor (CRF2)..."
A corticotropin-releasing factor type 2 receptor (CRF2 receptor) is a protein on the surface of certain cells that detects stress-related hormones and helps regulate the body's response to stress, mood, appetite and heart function. Investors care because drugs that block or activate this receptor can become treatments for conditions like anxiety, depression or metabolic disorders, and progress in clinical trials or regulatory signals can materially affect a company’s future revenue and risk profile.
peptide agonist medical
"NBIP-'2118 is an investigational corticotropin-releasing factor type 2 receptor (CRF2) peptide agonist..."
A peptide agonist is a short chain of amino acids designed to bind to and activate a specific cell receptor, like a key that fits a lock and turns on a biological switch. Investors care because these molecules can be developed into drugs that change how diseases are treated, so successful lab or clinical results, safety profiles, or approvals can materially affect a biotech company’s value and future revenue prospects.
subcutaneous medical
"designed for once-weekly subcutaneous administration."
Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.
glp-1 medical
"NBIP-'1968 is an investigational triple agonist targeting GLP-1, GIP, and glucagon receptors..."
GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.
gip medical
"NBIP-'1968 is an investigational triple agonist targeting GLP-1, GIP, and glucagon receptors..."
GIP commonly stands for Global Infrastructure Partners, a private investment firm that buys and manages large physical assets such as airports, power plants, toll roads and pipelines. Investors pay attention because when GIP acquires, invests in, or sells such assets it can alter cash flow, debt levels and long-term plans for those businesses—like a new landlord changing rents or making upgrades—affecting revenue, dividends and risk for shareholders and creditors.
fc domain medical
"triple-agonist (targeting GLP-1, GIP, glucagon receptors) conjugated to an antibody Fc domain..."
The Fc domain is the tail end of an antibody molecule that acts like a handle for the immune system, determining how the antibody is cleared from the body and whether it activates immune responses. For investors, changes or engineering of the Fc domain can alter a therapy’s dosing frequency, safety profile and commercial value — similar to redesigning a car’s fuel tank or brakes to improve range and safety.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
  • 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.

© 2026 Neurocrine Biosciences. Inc. All Rights Reserved.

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbip-2118-a-corticotropin-releasing-factor-type-2-receptor-agonist-302760552.html

SOURCE Neurocrine Biosciences, Inc.

FAQ

What did Neurocrine Biosciences (NBIX) announce about NBIP-'2118 on May 4, 2026?

They announced initiation of a Phase 1 first-in-human trial of NBIP-'2118 testing safety and tolerability. According to Neurocrine Biosciences, the study will evaluate single ascending doses versus placebo in adults, with initial data expected in 2027.

How is NBIP-'2118 designed to be administered in the NBIX Phase 1 study?

NBIP-'2118 is designed for once-weekly subcutaneous administration. According to Neurocrine Biosciences, the molecule is a CRF2 peptide agonist intended for weekly dosing in clinical testing.

What did preclinical studies show about NBIP-'2118's effect on body composition?

Preclinical models showed weight loss driven mainly by fat reduction while preserving or increasing lean mass. According to Neurocrine Biosciences, that profile differentiates NBIP-'2118 from some existing therapies.

When can investors expect initial human data for NBIP-'2118 (NBIX)?

Initial Phase 1 data is expected in 2027. According to Neurocrine Biosciences, the trial began May 4, 2026, and will report initial safety/tolerability readouts the following year.

How does NBIP-'2118 fit into Neurocrine's broader obesity strategy (NBIX)?

NBIP-'2118 is part of an integrated obesity program including NBIP-'1968 and conjugate approaches. According to Neurocrine Biosciences, the company plans combination strategies to aim for greater weight loss while sparing muscle.