Wegovy (semaglutide injection once weekly) / Novo Nordisk, Emcure - LARVOL DELTA

Wegovy Pill and Wegovy Pen Now Available with Hims & Hers - "...Hims & Hers is offering direct access to Wegovy pills, Wegovy injections and Ozempic injections at all dosage levels. With cash-pay prices starting at $149 a month..."

Commercial • Obesity

Novo Nordisk Cuts Wegovy Price in South Africa for a Second Time (Global Banking & Finance Review) - "The lowest injected dose of Wegovy has dropped from 3,090 rand ($183) to 1,873 rand, while the highest dose has fallen 27% to 3,746 rand. A further 12% cut to the 1.7 mg dose - the second highest - is awaiting approval, Leping said....Speaking on a panel at the event, Novo South Africa General Manager Sara Norcross said the company intends to introduce its Wegovy pill locally 'as soon as possible.'"

Pricing • Obesity

CLM-OB-001: WeDosify Real World Evidence (RWE) Study: Personalized Semaglutide Dosing in U.S. Adults (clinicaltrials.gov) - P=N/A | N=20 | Completed | Sponsor: Closed Loop Medicine | Recruiting ➔ Completed

HEOR • Real-world evidence • Trial completion • Genetic Disorders • Obesity

FDA approves Novo Nordisk’s new Wegovy HD injection, delivering the highest weight loss to date for a Wegovy injection, adding to its already expansive clinical profile (PRNewswire) - "The FDA approval of Wegovy HD is based on the results of the STEP UP trial program, which included STEP UP, a 72-week study which evaluated the efficacy and safety of once-weekly Wegovy 7.2 mg compared to placebo and Wegovy 2.4 mg, as an adjunct to lifestyle intervention in 1,407 adults with obesity (BMI 30 kg/m2 or greater), without diabetes....Wegovy HD will be available in April through all channels where patients can access Wegovy including 70,000 plus pharmacies in the US like CVS and Costco, select telehealth providers, NovoCare Pharmacy, GoodRx, and others."

Accelerated approval • FDA approval • Launch US • Obesity

Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Children's Hospital Los Angeles | Initiation date: Nov 2025 ➔ Jun 2026

Trial initiation date • Gastrointestinal Disorder • Genetic Disorders • Obesity • Pediatrics

The US Food and Drug Administration (FDA) has issued a warning letter to Novo Nordisk over failures in reporting suspected adverse side effects linked to the GLP-1 drugs Ozempic and Wegovy. (CNBC-TV18) - "In the letter and an accompanying inspection report, the FDA said Novo Nordisk did not report all suspected side effects in patients taking Ozempic. The agency said the cases included two deaths and a suicide....FDA investigators at the company’s US headquarters in Plainsboro said they found more than 300 adverse event reports that had not been submitted to the agency. Some reports were more than 1,000 days late. The cases included at least four deaths and a suicide. The FDA said the company did not promptly investigate a report in which a doctor told a company representative that a patient taking semaglutide was depressed and later committed suicide."

FDA event • Obesity • Type 2 Diabetes Mellitus

A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Shanghai World Leader Pharmaceutical Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

OBOE-Mayo: Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2028 ➔ Feb 2029

Enrollment open • Trial completion date • Bipolar Disorder • CNS Disorders • Genetic Disorders • Mood Disorders • Obesity • Psychiatry • Schizophrenia

Novo Nordisk ​said on Monday it will sell its blockbuster Wegovy and Ozempic drugs through the U.S. telehealth company Hims & Hers Health (HIMS.N), opens new tab platform, ‌ending a legal dispute that erupted last month. (Reuters) - "Under the agreement, Hims will offer approved Ozempic and Wegovy injectables, as well as the Wegovy pill, to U.S. consumers on its platform at ​Novo's self-pay prices. Hims had a short-lived agreement with Novo in 2025 to sell branded Wegovy. Hims will no longer advertise compounded GLP-1 drugs, though it will ​continue offering them when providers deem it clinically necessary. U.S. regulations allow companies to sell compounded versions of drugs in personalized doses not available in the branded forms, or with special ingredients....Novo Nordisk CEO Mike Doustdar said the Wegovy pill had generated more than 600,000 prescriptions since its launch two months ago, with telehealth partnerships accelerating uptake."

Commercial • Obesity

Two deaths reported to drugs regulator over possible link to weight-loss jabs (The Independent) - "The Medicine and Healthcare Regulatory Agency (MHRA) received reports of the deaths in 2024 and 2025. They were two of more than 500 adverse drug reaction reports submitted from Northern Ireland during that time, which were suspected to be tied to GLP-1 medications...Of the two deaths reported to the MHRA, one was made in connection with Mounjaro, while the other was linked to an unspecified semaglutide, the active ingredient in weight-loss jabs....Some 317 reports of suspected reactions were made in relation to Mounjaro, while 135 were made in relation to Wegovy."

Serious adverse event • Obesity

PLATEAU: Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Veru Inc.

New P2 trial • Genetic Disorders • Obesity

A blockbuster anti-obesity and diabetes drug could cost as little as $3 per month to manufacture once it goes off patent later this month… (Medical Xpress) - "Semaglutide, the active molecule in Novo Nordisk's Ozempic and Wegovy treatments, leads to considerable weight loss in patients and thus can provide major help in managing diabetes and other medical problems related to obesity....Using pricing information from other medicines that recently went off patent, researchers in Britain, South Africa, and New Zealand calculated the potential generic manufacturing price for semaglutide....They estimated it will cost as little as $3 to produce a month's supply of semaglutide, which in its branded form sells for around $200 a month in the United States."

Commercial • Obesity • Type 2 Diabetes Mellitus

Novo-Nordisk A/S (NVO.US) has submitted a new indication for semaglutide for market approval in China. (FUTU) - "Based on clinical trial and regulatory filing progress, it is speculated that the indication being applied for is metabolic dysfunction-associated steatohepatitis (MASH)."

China filing • Metabolic Dysfunction-Associated Steatohepatitis

Wegovy: Newly added patent in Orange Book (Orange Book) - Expiry on Oct 10, 2038

Patent • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

"Wegovy improves muscle quality and reduces visceral fat in Korean study" (BioNews) - "Lim further cited findings from a recent study involving 57,000 Korean adults...He noted, 'Approximately 24% of individuals classified as obese under the existing BMI criteria were not clinically obese.'...According to findings from the recently published 'SEMALEAN' study evaluating Wegovy, body fat mass declined by more than 14% after seven months of treatment and by approximately 19% after 12 months, with visceral fat showing a comparable reduction....Furthermore, the 'STEP 6' trial conducted on Asian populations, including Korean participants, reported that patients treated with Wegovy experienced a reduction of 40% in abdominal visceral fat area."

Retrospective data • Obesity

Wegovy reimbursement should start with severely obese and vulnerable groups, experts say (The Bio) - "Lim Soo, professor of the Department of Endocrinology at Seoul National University Bundang Hospital, welcomed the reimbursement of 'Ozempic,' a diabetes treatment containing semaglutide, during a meeting with reporters held on March 3 at the headquarters of Novo Nordisk Korea (hereinafter referred to as Novo) in Jamsil, Seoul. However, he noted that access to treatment for patients with obesity remains limited and added that discussions are currently underway with relevant academic societies regarding the potential expansion of reimbursement coverage for 'Wegovy,' an obesity treatment containing the same active ingredient."

Reimbursement • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk to invest $507 million in Ireland Plant for Wegovy Production (GxP News)

Commercial • Obesity

Novo Nordisk announces significant reduction in US list price for Wegovy, Ozempic, and Rybelsus (semaglutide medicines), building on continued efforts to expand access (PRNewswire) - "Today, Novo Nordisk announced that, effective January 1, 2027, the company will lower the list price, or wholesale acquisition cost (WAC), of Wegovy (semaglutide) injection 2.4 mg and tablets 25 mg, Ozempic (semaglutide) injection 0.5 mg, 1 mg, and 2 mg, and Rybelsus (semaglutide) tablets 7 mg or 14 mg to $675, representing reductions of approximately 50% and 35% for Wegovy and Ozempic, respectively, from the current list price."

Pricing • Cardiovascular • Chronic Kidney Disease • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk requests HSE to cover Wegovy on medical card (Irish Examiner) - "The HSE’s national centre for pharmacoeconomics is responsible for assessing the value for money of any new medications. It has to balance proven health benefits and the financial cost."

Reimbursement • Obesity

IIH:DUAL: The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure (clinicaltrials.gov) - P4 | N=38 | Completed | Sponsor: Rigmor Højland Jensen | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • CNS Disorders • Genetic Disorders • Hypertension • Obesity • Oncology • ADCYAP1 • IGF1

SLIM-1: Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Vivani Medical, Inc

New P1 trial • Genetic Disorders • Obesity

PILLAR: A Two-year Prospective, Observational Study of Wegovy in Real-world Clinical Practice (clinicaltrials.gov) - P=N/A | N=1250 | Enrolling by invitation | Sponsor: Novo Nordisk A/S | Recruiting ➔ Enrolling by invitation | Trial completion date: Oct 2027 ➔ Aug 2028 | Trial primary completion date: Oct 2027 ➔ Aug 2028

Enrollment status • Real-world evidence • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Wegovy…for weight loss not funded (PHARMAC) - "Specialist advisory group...met in December 2025 and reviewed the semaglutide funding application for weight loss. The group has provisionally recommended that Pharmac fund semaglutide (Wegovy) for chronic weight management in people with a high body mass index (BMI) and associated comorbidities, with a high priority. The full record of the meeting is expected to be available by March."

Reimbursement • Obesity

Predicting Long-Term Weight Loss Using Self-Reported, Digitally Collected, Real-World Data After Initiation of Semaglutide for Overweight or Obesity. (PubMed, Adv Ther) - "This study successfully applied an exposure-response weight predictor algorithm to self-reported data collected from users in the real world. Integrating weight predictors into digital PSPs may be valuable for both patients and HCPs in managing weight loss and setting or monitoring treatment targets."

Journal • Real-world evidence • Genetic Disorders • Obesity

Indian drugmaker Dr Reddy’s Laboratories…hopes to launch a generic version of Novo Nordisk’s…blockbuster weight‑loss drug Wegovy at a competitive price that could be up to 60% lower than the branded product… (Reuters)

Generic launch • Obesity