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Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'1968, a GLP-1/GIP/Glucagon Receptor Triple Agonist

(Neutral)
(Positive)

Neurocrine Biosciences (Nasdaq: NBIX) announced the initiation of a Phase 1 first-in-human clinical study of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity. The trial will initially assess safety and tolerability of single ascending doses in adults across overweight and obese body mass index categories.

NBIP-'1968 is an internally discovered, long-acting candidate designed for once-weekly subcutaneous administration, with balanced glucagon receptor activity to support tolerability while targeting appetite regulation, energy balance and glycemic control. It is intended for fixed-dose combination use with NBIP-'2118, a corticotropin-releasing factor type 2 receptor agonist also in Phase 1 development, within Neurocrine’s broader obesity portfolio.

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Positive

  • Phase 1 first-in-human trial initiated for NBIP-'1968 in obesity
  • Internally discovered once-weekly triple agonist expands obesity pipeline
  • NBIP-'1968 planned fixed-dose combination with Phase 1 asset NBIP-'2118

Negative

  • None.

Market Context

Net Selling insider activity provides a platform-level counterweight to this Phase 1 initiation. The...
Analysis

Net Selling insider activity provides a platform-level counterweight to this Phase 1 initiation. The tag-specific record includes both positive and negative clinical-trial reactions; short positioning was categorized as low, leaving safety data as the key watchpoint.

Key Figures

Trial Phase: Phase 1 Receptor Targets: 3 receptors Dosing Frequency: Once weekly
3 metrics
Trial Phase Phase 1 First-in-human study
Receptor Targets 3 receptors GLP-1, GIP and glucagon
Dosing Frequency Once weekly Subcutaneous administration

Previous Clinical trial Reports

5 past events · Latest: Jul 01 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 01 Phase 2 study initiation Positive +3.9% Initiated pediatric crinecerfont study with 20 participants and 24-week duration.
May 04 Phase 1 study initiation Positive +1.7% Initiated first-in-human NBIP-'2118 obesity study with single ascending doses.
Jan 26 Phase 2 study initiation Positive -1.2% Initiated randomized NBI-1065890 study targeting tardive dyskinesia in adults.
Dec 22 Phase 3 study update Negative -0.2% Valbenazine study failed to meet primary and key secondary endpoints.
Nov 10 Phase 2 results update Negative -1.8% NBI-1070770 failed its primary endpoint versus placebo in major depression.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical-trial announcements produced four aligned reactions and one divergence, with initiation news previously generating both positive and negative responses.

Key Terms

glp-1, gip, triple agonist, single ascending doses, +1 more
5 terms
glp-1 medical
"an investigational GLP-1/GIP/glucagon receptor triple agonist"
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
"an investigational GLP-1/GIP/glucagon receptor triple agonist"
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.
triple agonist medical
"an investigational GLP-1/GIP/glucagon receptor triple agonist being developed"
A triple agonist is a drug or biological agent designed to stimulate three distinct biological targets—usually receptors or signaling pathways—at the same time. Like a key that opens three different locks, it aims to produce a combined therapeutic effect; for investors this matters because such drugs can offer broader or complementary benefits but also bring greater scientific complexity, development risk, and regulatory scrutiny during clinical testing.
single ascending doses medical
"evaluate the safety and tolerability of single ascending doses"
A single ascending doses (SAD) study is an early-stage clinical trial format where different groups of participants each receive one dose of an experimental drug at progressively higher levels to test safety, tolerability, and how the body handles the drug. It matters to investors because SAD studies reveal initial safety and dosing information—like test-driving a car at increasing speeds—to gauge whether further, costlier trials are warranted and to reduce later-stage clinical risk.
subcutaneous administration medical
"designed for once-weekly subcutaneous administration"
Subcutaneous administration is delivering a drug by injection into the layer of tissue just under the skin, like placing a tiny reservoir beneath the surface with a short needle. For investors, this matters because how a medicine is given affects patient convenience, adherence, manufacturing and packaging needs, and potential market size—treatments that are easier or safer to administer often sell better and face different regulatory and cost considerations.

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  • Initiation of study marks an important milestone in advancing Neurocrine's obesity portfolio and investigational metabolic disease pipeline  

SAN DIEGO, Aug. 7, 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-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity.

"Obesity is a complex chronic disease driven by multiple biological pathways, underscoring the need for additional treatment options," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "NBIP-'1968 is designed to engage three complementary metabolic mechanisms, reflecting our commitment to exploring multiple scientific approaches to obesity."

The Phase 1 study initially will evaluate the safety and tolerability of single ascending doses of NBIP-'1968 in adult participants across a range of body mass index categories, including overweight and obese.

NBIP-'1968 is an internally discovered, investigational long-acting triple agonist designed for once-weekly subcutaneous administration. It targets the receptors for glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon to influence metabolic pathways involved in appetite regulation, energy balance and glycemic control. NBIP-'1968 was designed with balanced glucagon receptor activity to optimize the potential metabolic benefits of glucagon receptor activation while supporting tolerability.

Neurocrine is developing NBIP-'1968 as part of a broader obesity portfolio that includes NBIP-'2118, an investigational corticotropin-releasing factor type 2 receptor agonist currently in Phase 1 development. NBIP-'1968 is intended for use in a fixed-dose combination with NBIP-'2118. The company's obesity research also includes earlier-stage programs designed to explore complementary mechanisms and extended dosing intervals.

"Advancing NBIP-'1968 into the clinic marks another important step in building our obesity portfolio," said Jude Onyia, Ph.D., Chief Scientific Officer, Neurocrine Biosciences. "Our strategy is to explore complementary and differentiated mechanisms that may improve weight loss, preserve lean mass and ultimately address the diverse needs of people living with obesity."

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, obstructive sleep apnea, metabolic dysfunction-associated steatohepatitis/fatty liver disease, certain cancers and osteoarthritis. It is driven by complex biological, environmental, and genetic factors – not simply lifestyle or willpower. Obesity has reached epidemic levels worldwide, affecting a significant proportion 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. Current therapies can have challenges with respect to gastrointestinal tolerability, dose titration, and muscle loss.

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, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine 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, hyperphagia in Prader-Willi syndrome, 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 more than 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 quarterly report on Form 10-Q for the quarter ended June 30, 2026. 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.

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SOURCE Neurocrine Biosciences, Inc.

FAQ

What did Neurocrine Biosciences (NBIX) announce about NBIP-'1968 on August 7, 2026?

Neurocrine Biosciences announced starting a Phase 1 first-in-human study of NBIP-'1968 for obesity. According to Neurocrine Biosciences, this early trial will evaluate safety and tolerability using single ascending doses in adult participants with overweight and obesity across different body mass index ranges.

What is NBIP-'1968 in Neurocrine Biosciences' (NBIX) obesity pipeline?

NBIP-'1968 is an investigational GLP-1/GIP/glucagon receptor triple agonist targeting obesity. According to Neurocrine Biosciences, it is a long-acting, once-weekly subcutaneous therapy designed to influence appetite regulation, energy balance and glycemic control through three complementary metabolic pathways, with balanced glucagon receptor activity to support tolerability.

What does the Phase 1 clinical trial of NBIP-'1968 evaluate for Neurocrine Biosciences (NBIX)?

The Phase 1 trial evaluates the safety and tolerability of single ascending doses of NBIP-'1968. According to Neurocrine Biosciences, the study involves adult participants across overweight and obese BMI categories, providing initial human data for this triple agonist obesity candidate in early clinical development.

How will NBIP-'1968 be administered in Neurocrine Biosciences' (NBIX) clinical program?

NBIP-'1968 is designed for once-weekly subcutaneous administration as part of Neurocrine’s obesity strategy. According to Neurocrine Biosciences, the investigational triple agonist is long-acting and intended for use in a fixed-dose combination regimen with NBIP-'2118, another Phase 1 obesity candidate.

How does NBIP-'1968 fit into Neurocrine Biosciences' (NBIX) broader obesity portfolio?

NBIP-'1968 is a core component of Neurocrine’s expanding obesity portfolio focused on complementary mechanisms. According to Neurocrine Biosciences, it is intended for fixed-dose combination with NBIP-'2118 and is supported by earlier-stage programs exploring additional pathways and extended dosing intervals for people living with obesity.

What metabolic pathways does NBIP-'1968 target in Neurocrine Biosciences' (NBIX) obesity program?

NBIP-'1968 targets GLP-1, GIP and glucagon receptors to modulate key metabolic pathways. According to Neurocrine Biosciences, this triple agonist approach aims to affect appetite regulation, energy balance and glycemic control while using balanced glucagon receptor activity to optimize potential benefits and maintain tolerability.