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Oral semaglutide

Oral semaglutide

Drug

Drug Profile

Oral semaglutide is a tablet formulation of semaglutide marketed as Rybelsus for adults with type 2 diabetes and cardiovascular risk reduction in high-risk populations. It is a GLP-1 receptor agonist and is taken orally once daily. FDA first approved Rybelsus in September 2019.

Drug Class: Oral GLP-1 receptor agonist
Approval Status: FDA approved; first approved September 20, 2019.
Mechanism of Action: GLP-1 receptor agonism with glucose-dependent stimulation of insulin secretion and suppression of glucagon.

Brand Names

Rybelsus

Indications

\Type 2 diabetes mellitus (adjunct to diet and exercise)\
\Cardiovascular risk reduction in adults with type 2 diabetes at high risk\

Related News

Oral Semaglutide Compounding Faces Regulatory Crackdown After Hims & Hers Initiative

Apr 01, 2026

The FDA has shifted from regulatory ambiguity to coordinated enforcement against compounded oral semaglutide, culminating in a 2026 announcement of intent to take action against non-approved GLP-1 drugs. Hims & Hers Health's 2024 oral semaglutide offering marked the beginning of a broader regulatory reckoning that saw manufacturer pressure, formal shortage declarations, and warning letters targeting compounding practices.

Oral Semaglutide Shows Broad Cardiometabolic Benefits in Type 2 Diabetes Trial

Mar 25, 2026

Oral semaglutide demonstrated significant improvements in multiple cardiometabolic risk factors in adults with type 2 diabetes at high cardiovascular risk. The SOUL trial analysis showed reductions in systolic blood pressure, cholesterol, triglycerides, HbA1c, and body weight compared to placebo. These benefits were observed as early as 13 weeks and contributed to a 14% reduction in major adverse cardiovascular events.

Lilly's Orforglipron Outperforms Oral Semaglutide in Head-to-Head Phase 3 Trial

Mar 14, 2026

Eli Lilly's orforglipron demonstrated superior A1C reduction and weight loss compared to oral semaglutide in the ACHIEVE-3 trial, with regulatory submissions filed in over 40 countries and a potential US decision expected in Q2 2026.

Orforglipron Shows Superior Glycemic Control Over Oral Semaglutide in Type 2 Diabetes

Mar 08, 2026

Orforglipron, an oral GLP-1 receptor agonist, demonstrated greater reductions in HbA1c and body weight compared to oral semaglutide in adults with type 2 diabetes, with more patients achieving strict glycemic targets at one year.

Oral Semaglutide Reduces Heart Failure Events in Type 2 Diabetes Patients With Prior HF

Mar 03, 2026

A secondary analysis of the SOUL trial shows oral semaglutide significantly lowers heart failure-related events in type 2 diabetes patients with preexisting heart failure, particularly those with preserved ejection fraction, without increasing serious adverse events.

Oral Semaglutide Reduces Heart Failure Risk in Type 2 Diabetes Patients

Feb 28, 2026

Oral semaglutide reduced heart failure events by 22% in Type 2 diabetes patients with existing heart failure in a trial of nearly 9,650 adults, with particular benefit in HFpEF cases.

Eli Lilly's Orforglipron Shows Greater Weight Loss Than Oral Semaglutide in Phase 3 Trial

Feb 26, 2026

Eli Lilly's oral GLP-1 drug orforglipron demonstrated 6-8% weight loss in type 2 diabetes patients compared to 4-5% with oral semaglutide in a phase 3 trial, though discontinuation rates were higher due to gastrointestinal side effects.

GLP-1 Drug Waste and Supplement Market Growth Amid Rising Ozempic Use

Feb 23, 2026

Millions of single-use GLP-1 pens may be improperly disposed of annually, while the supplement industry responds to nutritional gaps created by reduced food intake among users of drugs like Ozempic and Wegovy.

GLP-1 Receptor Agonists: Fertility, Pregnancy Safety, and Treatment Considerations

Feb 18, 2026

GLP-1 receptor agonists like semaglutide and liraglutide may improve fertility through metabolic benefits but are not recommended during pregnancy. Current guidance advises discontinuing long-acting agents at least two months before conception.

Novo Nordisk Rebrands Rybelsus as Oral Ozempic, Sues Hims & Hers Over Compounded Semaglutide

Feb 17, 2026

Novo Nordisk announced on February 4, 2026, that oral semaglutide previously marketed as Rybelsus will be rebranded as oral Ozempic, with availability expected in Q2 2026. The company also filed a patent infringement lawsuit against Hims & Hers over compounded oral semaglutide products.

Related Clinical Trials

NCT ID	Title	Status	Phase
NCT07390110	Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL)	ACTIVE_NOT_RECRUITING
NCT07271251	A Research Study to See if Two Different Formulations of Oral Semaglutide Are Equally Safe and Effective in Reducing the Blood Sugar Level in Japanese People With Type 2 Diabetes	ACTIVE_NOT_RECRUITING	PHASE3
NCT07225816	Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)	RECRUITING	PHASE1
NCT07056803	Oral vs. Subcutaneous Semaglutide in Type 2 Diabetes Mellitus	COMPLETED
NCT06792422	A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma	RECRUITING	PHASE4
NCT06659718	Emulation of the SOUL Diabetes Trial in Healthcare Claims	COMPLETED
NCT06613854	Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes	RECRUITING	PHASE4
NCT06269120	SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary	RECRUITING
NCT06003153	GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH	RECRUITING	PHASE4
NCT05502562	A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India	COMPLETED