This section highlights FDA-related milestones and regulatory updates for drugs developed by Novo Nordisk A/S (NVO).
Over the past two years, Novo Nordisk A/S has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CagriSema, liraglutide, semaglutide, Sogroya, and Wegovy. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CagriSema - FDA Regulatory Timeline and Events
CagriSema is a drug developed by Novo Nordisk A/S for the following indication: people with obesity or overweight and type 2 diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CagriSema
- Announced Date:
- March 10, 2025
- Indication:
- people with obesity or overweight and type 2 diabetes
Announcement
Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo.
AI Summary
Novo Nordisk has announced headline results from the REDEFINE 2 trial, part of its global REDEFINE program. This phase 3 study evaluated the long-term efficacy and safety of once-weekly subcutaneous CagriSema—a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg—against a placebo over 68 weeks. The study aimed to determine whether the new treatment could offer a significant benefit in weight management compared to a placebo, while also confirming its safety for long-term use.
The trial’s results mark an important step in Novo Nordisk’s efforts to develop innovative therapies for weight loss. By focusing on both safety and effectiveness over an extended period, the REDEFINE 2 trial provides valuable evidence that could shape future treatment options for patients struggling with weight-related issues. More detailed information on the trial outcomes is expected as the company moves forward with its regulatory plans.
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liraglutide - FDA Regulatory Timeline and Events
liraglutide is a drug developed by Novo Nordisk A/S for the following indication: For type 2 diabetes, and chronic obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- liraglutide
- Announced Date:
- September 11, 2024
- Indication:
- For type 2 diabetes, and chronic obesity.
Announcement
Novo Nordisk announced that its weight-loss drug liraglutide is safe and effective for children as young as six. The company-funded study revealed a 7.4% reduction in body-mass index for children aged 6 to 12 using the injectable pens over a year compared to a placebo group.
AI Summary
Novo Nordisk has announced that its weight-loss drug liraglutide is safe and effective for children as young as six. In a company-funded study with 82 participants aged 6 to 12, children using the injectable pens showed an average 7.4% reduction in body-mass index over one year compared to those given a placebo. This finding suggests that liraglutide may become the first obesity treatment available for young children, a significant development since childhood obesity is a key predictor of adult obesity.
Although some side effects like nausea and vomiting were noted, the study reported no differences in growth, bone age, or puberty onset between the two groups. With these promising results, Novo Nordisk plans to seek regulatory approval in both the U.S. and Europe, potentially offering a new option for tackling childhood obesity.
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semaglutide 7.2 mg - FDA Regulatory Timeline and Events
semaglutide 7.2 mg is a drug developed by Novo Nordisk A/S for the following indication: For the treatment of obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- semaglutide 7.2 mg
- Announced Date:
- January 17, 2025
- Indication:
- For the treatment of obesity
Announcement
Novo Nordisk announced headline results from STEP UP, a phase 3b trial in the global STEP programme.
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Sogroya - FDA Regulatory Timeline and Events
Sogroya is a drug developed by Novo Nordisk A/S for the following indication: efficacious and well-tolerated long-acting growth hormone in children with growth disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sogroya
- Announced Date:
- May 12, 2025
- Indication:
- efficacious and well-tolerated long-acting growth hormone in children with growth disorders
Announcement
Novo Nordisk today presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature (ISS)3.
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Wegovy - FDA Regulatory Timeline and Events
Wegovy is a drug developed by Novo Nordisk A/S for the following indication: For cardiovascular risk reduction in adults with known heart disease and overweight or obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Wegovy
- Announced Date:
- June 26, 2025
- Estimated Event Date Range:
- July 1, 2025 - July 1, 2025
- Target Action Date:
- July 1, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
Novo Nordisk continues expansion of patient access to Wegovy® (semaglutide) injection 2.4 mg through a new collaboration with WeightWatchers, a global leader in science-backed weight management, beginning July 1, 2025.
AI Summary
Starting July 1, 2025, Novo Nordisk is expanding patient access to its FDA-approved Wegovy® (semaglutide) injection 2.4 mg in a new collaboration with WeightWatchers, a leader in science-based weight management. Through this partnership, WeightWatchers will work with CenterWell Pharmacy to manage prescription fulfillment and home delivery for patients using NovoCare® Pharmacy. The initiative is designed to provide an integrated support system that combines convenient access to effective medication with lifestyle guidance, aiming to improve long-term health outcomes for those living with chronic obesity. This new approach reinforces Novo Nordisk’s commitment to making safe and effective treatments more accessible through partnerships with companies that share its patient-focused values. Additionally, a special introductory offer of $299 for self-paying patients will be available from July 1 to July 31, 2025, enhancing the affordability of Wegovy® for new patients.
Read Announcement- Drug:
- Wegovy
- Announced Date:
- May 2, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.
Read Announcement- Drug:
- Wegovy
- Announced Date:
- April 29, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
LifeMD, Inc announced plans to offer broad, affordable, and streamlined access to Wegovy® (semaglutide) through NovoCare® Pharmacy.
AI Summary
LifeMD, Inc. announced plans to offer broad, affordable, and streamlined access to Wegovy® (semaglutide) through its partnership with NovoCare® Pharmacy. This new integration will allow cash-pay patients to access all FDA-approved dose strengths of Wegovy® directly within LifeMD’s virtual care platform. The service is part of LifeMD’s fast-growing weight management program and is designed to simplify the patient journey by offering a convenient, end-to-end digital care experience.
The program not only includes virtual consultations, lab testing, and personalized diet and lifestyle support but also offers a recently reduced self-pay cost of $499 per month for Wegovy®. With direct access to the medication and home delivery through NovoCare® Pharmacy, LifeMD aims to expand access to this critical treatment and improve the overall patient experience in managing obesity.
Read Announcement- Drug:
- Wegovy
- Announced Date:
- January 27, 2025
- Indication:
- For cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Announcement
Veru Inc. announced positive topline results from the Phase 2b QUALITY clinical study.
AI Summary
Veru Inc. announced positive topline results from its Phase 2b QUALITY clinical study. The study tested the use of enobosarm with WEGOVY (semaglutide) in older adults who are overweight or have obesity. Results showed that patients receiving enobosarm experienced 71% less loss of lean muscle compared to those taking WEGOVY alone. Although the overall weight loss was similar between the groups, enobosarm treatment led to a greater reduction in fat mass. The study also reported that fewer patients on enobosarm suffered a significant decline in physical function, as measured by a stair climb test.
These findings suggest that enobosarm may help preserve muscle while enhancing fat loss during weight reduction therapies. The promising results have encouraged Veru Inc. to plan further discussions with the FDA and additional studies to advance this treatment approach.
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