UBT251 / United Laboratories, Novo Nordisk - LARVOL DELTA

Novo Nordisk recently initiated a global phase 1b/2a trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of different doses of UBT251 for up to 28 weeks in around 330 people living with overweight or obesity. (GlobeNewswire) - "Topline data from that trial is expected in 2027. Novo Nordisk also expects to initiate a phase 2 trial with UBT251 in people with type 2 diabetes in the second half of 2026."

New P2 trial • P1/2 data • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk: Triple agonist UBT251 delivers up to 19.7% mean weight loss after 24 weeks in phase 2 trial in China (GlobeNewswire) - "From a baseline mean body weight of 92.2 kg, the highest mean weight loss observed for people treated with UBT251 was 19.7% (-17.5 kg) compared to 2.0% (-1.6kg) in the placebo group after 24 weeks of treatment...Moreover, all dose groups of UBT251 showed statistically significant improvements relative to placebo on key secondary endpoints, including waist circumference, blood glucose, blood pressure and lipids...'We look forward to reporting data from a global trial with UBT251 conducted by Novo Nordisk next year.'...United Biotechnology will present detailed data from the Chinese phase 2 trial at a medical congress later this year. Based on the results of this trial, the company is planning to initiate a phase 3 trial in Chinese patients with overweight or obesity."

New P3 trial • P2 data • Obesity

Novo Nordisk Expands Obesity Pipeline With New Phase 2 Trial for UBT251 (TipRanks) - "This is a Phase 2 interventional trial where participants are randomly assigned to different groups. It uses a parallel design, meaning groups are treated at the same time, and it is double-blinded so neither patients nor doctors know who gets UBT251 or placebo, with the main goal being treatment of overweight and obesity."

Trial status • Obesity

A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity (clinicaltrials.gov) - P2 | N=333 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity (clinicaltrials.gov) - P2 | N=333 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P2 trial • Genetic Disorders • Obesity

Mass balance study of [14C]UBT251 injection in healthy male subjects in China (ChiCTR) - P1 | N=6 | Not yet recruiting | Sponsor: Affiliated Hospital of Jiangnan University; Federal Biotechnology (Zhuhai Hengqin) Co., LTD

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase I Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Injection of UBT251 in Healthy Subjects (ChiCTR) - P1 | N=54 | Completed | Sponsor: The Third Xiangya Hospital Central South University; The Third Xiangya Hospital Central South University

New P1 trial • Diabetes • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Efficacy and Safety of UBT251 Injection in Subjects with Overweight or Obesity (ChiCTR) - P2 | N=200 | Completed | Sponsor: The Second Xiangya Hospital of Central South University; The United Bio-Technology (Hengqin) Co., Ltd

New P2 trial • Genetic Disorders • Obesity

UBT251 Injection Phase II Clinical Study (CKD) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Genetic Disorders • Nephrology • Obesity • Renal Disease

Pharmacokinetic Study of UBT251 Injection in Subjects with Normal Renal Function and Renal Insufficiency (ChiCTR) - P=N/A | N=24 | Not yet recruiting | Sponsor: The Third Xiangya Hospital of Central South University; Third Xiangya Hospital, Central South University

New trial • Nephrology • Renal Disease

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus (ChiCTR) - P2 | N=210 | Completed | Sponsor: The Second Xiangya Hospital of Central South University; Federal Biotechnology (Zhuhai Hengqin) Co., LTD

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

UBT251 Injection Phase II Study (Overweight or Obesity) (clinicaltrials.gov) - P2 | N=205 | Active, not recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

T2DM: UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study (clinicaltrials.gov) - P2 | N=211 | Active, not recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) (clinicaltrials.gov) - P2 | N=156 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

UBT251 Injection Phase II Clinical Study (CKD) (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Chronic Kidney Disease • Genetic Disorders • Nephrology • Obesity • Renal Disease

A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of UBT251 injection in obese/overweight chronic kidney disease (CKD) population (ChiCTR) - P2 | N=180 | Not yet recruiting | Sponsor: Peking University First Hospital; Federal Biotechnology (Zhuhai Hengqin) Co., Ltd

New P2 trial • Chronic Kidney Disease • Nephrology • Obesity • Renal Disease

New hope! UBT251 injection starts clinical trial in the treatment of obese chronic kidney disease [Google translation] (Sohu.com) - "According to the latest clinical trial progress, UBT251 injection of United Biotech (Zhuhai Hengqin) Co., Ltd. is committed to bringing new treatment options to patients with chronic kidney disease who are overweight or obese...The Phase II clinical trial of UBT251 injection was launched on July 14, 2025. The main purpose is to evaluate the efficacy and safety of different doses of UBT251 in obese/overweight chronic kidney disease patients. The drug is injected subcutaneously once a week for 24 weeks and is expected to provide treatment for 180 patients."

Trial status • Chronic Kidney Disease • Obesity

United Pharmaceuticals receives upfront payment from Novo Nordisk for exclusive license agreement for UBT251 [Google translation] (Sina Corp) - "Federal Pharma...announced that on June 20, 2025, Federal Biotech had received an advance payment of US$180 million (after deducting Danish withholding tax) from Novo Nordisk....Under the exclusive license agreement and subject to the terms and conditions thereof, Commonwealth Biotech will be eligible to receive further potential milestone payments of up to $1.8 billion, contingent upon the achievement of certain development and sales milestones, as well as tiered royalties based on annual net sales in the region."

Financing • Obesity

The United Laboratories and Novo Nordisk announce exclusive license agreement for UBT251, a GLP-1/GIP/glucagon triple receptor agonist (GlobeNewswire) - "The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology), have entered into an exclusive license agreement for UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon in early-stage clinical development for the treatment of obesity, type 2 diabetes, and other diseases....United Biotechnology will retain the rights for UBT251 in Chinese mainland, Hong Kong, Macau, and Taiwan. United Biotechnology is eligible to receive an upfront payment of 200 million US dollars and potential milestone payments of up to 1.8 billion dollars from Novo Nordisk, as well as tiered royalties on net sales outside of Chinese mainland, Hong Kong, Macau, and Taiwan."

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

UBT251 injection developed by United Laboratories (03933) for CKD indication has been approved by the US FDA for new drug clinical trials [Google translation] (Sina Corp) - "United Pharmaceutical....announced that recently, the UBT251 injection, a Class 1 innovative drug independently developed by the company's wholly-owned subsidiary United Biotech (Zhuhai Hengqin) Co., Ltd., has been approved by the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial for the indication of chronic kidney disease (CKD)."

New P2 trial • Chronic Kidney Disease

United Lab (03933): UBT251 injection for chronic kidney disease indication received implicit approval for clinical trials [Google translation] (Zhitong Finance) - "According to the Zhitong Finance APP, Federal Pharmaceutical...announced that on January 20, 2025, the company's wholly-owned subsidiary Federal Biotech (Zhuhai Hengqin) Co., Ltd.'s independently developed Class 1 innovative drug UBT251 injection for the indication of chronic kidney disease received implicit clinical trial approval from the China National Medical Products Administration, with acceptance number CXHL2401227."

New trial • Chronic Kidney Disease

Hong Kong Stocks Move | United Laboratories (03933) rose more than 5%. Recently, UBT251 injection for chronic kidney disease indications received implicit approval for clinical trials [Google translation] (163.com) - "On the news front, Federal Pharmaceutical announced that on January 20, 2025, the registration application for the Phase II clinical trial of UBT251 injection, a Class 1 innovative drug independently developed by the company's wholly-owned subsidiary Federal Biotech (Zhuhai Hengqin) Co., Ltd., for the indication of chronic kidney disease was granted implicit clinical trial approval by the China National Medical Products Administration."

New P2 trial • Chronic Kidney Disease