Lexicon Pharmaceuticals and Novo Nordisk Announce initiation of Phase 1 study with oral obesity drug candidate LX9851

Lexicon Pharmaceuticals (Nasdaq: LXRX) and Novo Nordisk announced initiation of a Phase 1 study of LX9851, an oral non-incretin candidate for obesity.

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) and Novo Nordisk announced initiation of a Phase 1 study of LX9851, an oral non-incretin candidate for obesity.

Lexicon earned a second $10 million milestone in 2026, may earn a third this year, and is eligible for up to $1 billion in total payments plus tiered royalties. The 96-subject trial is expected to complete in Q1 2027.

Positive

• Second $10M milestone earned following initial Phase 1 dosing
• Eligible for up to $1B in upfront and milestone payments
• Tiered royalties on net sales provide upside if commercialized
• Phase 1 initiated with 96 people with overweight or obesity
• Trial completion targeted in Q1 2027

Negative

• Early-stage program (Phase 1): efficacy and safety in larger populations unproven
• Material commercial payments depend on future development and sales milestones

Argus Mar 23 session

+5.13% close to close Open Argus

Details

News Market Reaction – LXRX

On Mar 23, the day this news came out, LXRX closed 5.13% above the previous close.

Data tracked by StockTitan Argus for the Mar 23 session.

Market Context

On Mar 23, the day this news came out, the stock closed 5.1% above the previous close. A strong posi...

Analysis

On Mar 23, the day this news came out, the stock closed 5.1% above the previous close. A strong positive reaction aligns with the significance of a first-in-class obesity candidate entering Phase 1 under a major partner. Past clinical headlines produced large moves, including both rallies and steep declines, so volatility around LX9851 updates would not be unusual. Investors could weigh the $10 million milestones and eligibility for up to $1 billion in payments against trial execution risk and broader biotech sentiment.

Key Figures

Near-term milestone: $10 million Potential near-term milestone: $10 million Total potential payments: $1 billion +5 more

Near-term milestone

$10 million

Second milestone payment earned from Novo Nordisk in 2026

Potential near-term milestone

$10 million

Third milestone payment that may be achieved later in 2026

Total potential payments

$1 billion

Maximum upfront and milestone payments under LX9851 collaboration

Phase 1 sample size

96 people

Participants with overweight or obesity in LX9851 Phase 1 study

Study completion timing

Q1 2027

Expected completion of LX9851 Phase 1 trial

Dose design

Single and multiple ascending doses

LX9851 Phase 1 design versus placebo

Potential milestone tranches

Three $10 million milestones

Series of near-term milestones tied to LX9851 development

Study population

Overweight or obesity

Target population for LX9851 Phase 1 investigation

Previous Clinical trial Reports

5 past events · Latest: Jan 21

Same Type 5 events

1. Jan 21

   End-of-Phase 2 FDA

   24h Move

   +19.1%

   FDA raised no objections to advancing pilavapadin into Phase 3.

2. Dec 05

   HFpEF adipose data

   24h Move

   -1.4%

   Presentation of sotagliflozin adipose distribution data at CVCT 2025.

3. Nov 08

   HFpEF efficacy data

   24h Move

   +13.6%

   Statistically significant HFpEF benefits without diabetes in SOTA P CARDIA trial.

4. Mar 03

   Phase 2b PROGRESS topline

   24h Move

   -58.2%

   PROGRESS met objectives but missed primary endpoint statistical significance.

5. Mar 02

   PROGRESS results preview

   24h Move

   -58.2%

   Announcement of upcoming Phase 2b PROGRESS topline results webcast.

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

Key Terms

phase 1, placebo, pharmacokinetics, pharmacodynamics, +1 more

5 terms

phase 1 medical

"Novo Nordisk has initiated a Phase 1 study with LX9851, a first-in-class..."

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

placebo medical

"doses of LX9851 compared to placebo in 96 people with overweight or obesity."

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

pharmacokinetics medical

"investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of..."

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pharmacodynamics medical

"safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple..."

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

non-incretin medical

"LX9851 is a first-in-class, oral non-incretin candidate being developed..."

Non-incretin describes a drug, treatment, or biological effect that works without involving incretins—gut hormones (such as GLP‑1) that help control insulin and blood sugar. For investors, labeling a therapy non-incretin signals a different mechanism of action, which can mean distinct safety, effectiveness, regulatory hurdles and market positioning; think of it as choosing a different engine type with its own costs, benefits and customer niche.

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

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LX9851 is a first-in-class, oral non-incretin candidate being developed by Novo Nordisk for the treatment of obesity and associated metabolic disorders

Lexicon has earned a second of three potential $10 million near-term milestone payments and is eligible to receive up to $1 billion in total upfront and milestone payments from the collaboration, plus royalties on net sales

THE WOODLANDS, Texas, March 23, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) and Novo Nordisk A/S today announced that Novo Nordisk has initiated a Phase 1 study with LX9851, a first-in-class, oral non-incretin development candidate.

In March 2025, Lexicon signed an exclusive license agreement with Novo Nordisk for LX9851 in obesity and associated metabolic disorders. Under the terms of the agreement, Novo Nordisk obtained an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications.

Lexicon has earned a second $10 million milestone payment in 2026 from Novo Nordisk following initial dosing requirements in the Phase 1 study and is eligible for a third $10 million milestone payment that may be achieved later this year. In total, Lexicon is eligible to receive up to $1 billion in upfront and potential development, regulatory and sales milestone payments. Lexicon is also entitled to tiered royalties on net sales of LX9851.

“We are thrilled with the progress of the Novo Nordisk team on initiating the clinical development of LX9851,” said Mike Exton, CEO and director of Lexicon. “The talented team at Novo Nordisk has recognized the significant potential for LX9851, a novel, oral candidate for obesity and has moved swiftly to advance the program in its pipeline. We believe LX9851 has the potential to become a differentiated approach in the next phase of treatments for obesity and metabolic disease.”

“We are excited about the potential of LX9851 and pleased to take it into clinical testing to further explore the potential of the candidate,” said Jacob Sten Petersen, Senior Vice President and Head of Global Research at Novo Nordisk. “LX9851 offers a novel approach to the treatment of obesity and related metabolic conditions. It is an important addition to our pipeline of potential treatment options as we look to meet the diverse needs of people living with obesity, diabetes and their associated comorbidities.”

The Phase 1 study is investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of LX9851 compared to placebo in 96 people with overweight or obesity. The trial is expected to be completed in the first quarter of 2027.

About LX9851
LX9851, discovered by Lexicon and in development by Novo Nordisk, is a potent and selective oral small molecule inhibitor of Acyl CoA Synthetase 5 (ACSL5)​. ACSL5 plays a key role in the metabolic pathway which regulates fat accumulation and energy balance. Additionally, LX9851 may activate the ileal brake mechanism leading to increased satiety by delaying gastric emptying and suppressing appetite. Preclinical in vivo efficacy data presented at Obesity Week 2024 show that LX9851, when combined with semaglutide, significantly reduced weight, food intake and fat mass compared to semaglutide alone. Separately, LX9851 mitigated weight regain and had positive effects on liver steatosis when introduced after semaglutide discontinuation.

About Lexicon Pharmaceuticals 
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.

Safe Harbor Statement   
This press release contains “forward-looking statements,” including statements relating to the preclinical and clinical development of LX9851, Lexicon’s financial position and long-term outlook on its business, growth and future operating results, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.  

For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Lexicon (LXRX) and Novo Nordisk announce on March 23, 2026 about LX9851?

They announced initiation of a Phase 1 study for LX9851, an oral non-incretin candidate for obesity. According to the company, the trial will enroll 96 people and assesses safety, tolerability, pharmacokinetics and pharmacodynamics.

How much milestone money has Lexicon (LXRX) received related to LX9851 so far in 2026?

Lexicon has earned a $10 million milestone payment in 2026 tied to initial dosing in the Phase 1 study. According to the company, a third $10 million milestone may be achieved later this year.

What is the total financial upside for Lexicon (LXRX) from the Novo Nordisk collaboration on LX9851?

Lexicon is eligible to receive up to $1 billion in upfront and potential development, regulatory and sales milestone payments. According to the company, Lexicon will also earn tiered royalties on net sales.

What are the design and timeline details of the LX9851 Phase 1 trial (LXRX)?

The Phase 1 trial is a single and multiple ascending dose study vs placebo in 96 people with overweight or obesity. According to the company, the trial is expected to complete in Q1 2027.

Does the Phase 1 start for LX9851 (LXRX) indicate commercial readiness?

No, Phase 1 initiation indicates early clinical testing focused on safety and PK, not commercialization. According to the company, further trials and milestones are required before any regulatory approvals or sales.

What rights did Novo Nordisk obtain under the LX9851 license with Lexicon (LXRX)?

Novo Nordisk obtained an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in obesity and related metabolic disorders. According to the company, Lexicon retains eligibility for milestones and royalties.