Which GLP-1 Are Approved for Weight Loss?

Last reviewed: June 4, 2026

Last updated: June 4, 2026

Written by: Jay Hastings, CEO of PlexusDx

Jay Hastings is the CEO of PlexusDx, a precision health company focused on genetic testing, blood biomarker insights, and personalized wellness recommendations. He has more than 20 years of experience across healthcare innovation, genomics, laboratory operations, healthcare investing, and strategic finance.

Medically reviewed by: Jayden Lee, PharmD, EMBA

Jayden Lee, PharmD, EMBA, is the PlexusDx Medical Science Liaison with a PharmD and MBA specializing in pharmacogenomics and clinical product development, with a proven ability to bridge the gap between genomic research and practical patient outcomes. Dr. Lee has more than 10 years of professional experience in clinical pharmacy, academia, and research.

Four FDA-approved products currently carry a chronic weight management indication: Wegovy (semaglutide, injection and tablets), Zepbound (tirzepatide), Saxenda (liraglutide 3 mg) and Foundayo (orforglipron), approved April 1, 2026. The products people most often name — Ozempic, Mounjaro and Rybelsus — do not, because they are type 2 diabetes products. Being precise here is not pedantry: coverage, prior authorization criteria and diagnosis coding all key off the approved indication rather than the active ingredient.

Wegovy: The Broadest Semaglutide Label

Wegovy injection is indicated, in combination with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition.

It also carries an indication to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, and an accelerated approval for noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis in adults.

Wegovy tablets, approved December 22, 2025, sit inside the same prescribing information at 1.5, 4, 9 and 25 mg but carry only the cardiovascular risk reduction and weight reduction indications — not the pediatric use and not MASH. Wegovy injection's labeled maximum is now 7.2 mg once weekly, following the Wegovy HD approval of March 19, 2026.

Zepbound: Tirzepatide for Weight and for Sleep Apnea

Zepbound is indicated for chronic weight management in adults with obesity, or with overweight plus at least one weight-related condition, in combination with a reduced-calorie diet and increased physical activity.

It holds a second indication for moderate to severe obstructive sleep apnea in adults with obesity, granted in December 2024 on the basis of two 52-week randomised placebo-controlled studies in 469 adults. It was the first medication approved for that condition.

Its efficacy evidence comes from the SURMOUNT programme. SURMOUNT-1 ran 72 weeks in 2,539 adults with obesity or overweight, excluding diabetes, and reported mean weight changes of −15.0%, −19.5% and −20.9% versus −3.1% with placebo.

The Two Older and Newer Outliers

Saxenda is liraglutide at 3 mg daily, approved for chronic weight management well before the current generation. It is a daily injection rather than a weekly one, and its mean weight reductions in trials were smaller than those seen with semaglutide or tirzepatide.

Foundayo (orforglipron) was approved April 1, 2026 as an oral tablet in strengths of 0.8, 2.5, 5.5, 9, 14.5 and 17.2 mg, indicated for chronic weight management in adults with obesity or with overweight plus at least one weight-related comorbidity.

Foundayo is a small molecule rather than a peptide, which is why it can be formulated as a conventional tablet. Its labeling carries an explicit limitation of use against concomitant use with another GLP-1 receptor agonist.

The Products Without a Weight Indication

Ozempic holds three type 2 diabetes indications: glycemic control, reduction of major adverse cardiovascular events in patients with established cardiovascular disease, and reduction of sustained eGFR decline, end-stage kidney disease and cardiovascular death in patients with chronic kidney disease. There is no BMI eligibility criterion anywhere in its label.

Mounjaro is indicated only as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Rybelsus and Ozempic tablets share a label covering glycemic control and cardiovascular risk reduction in type 2 diabetes.

There is no FDA-approved oral tirzepatide and no oral Zepbound. Retatrutide remains investigational, is not approved for any use, and cannot lawfully be used in compounding.

Why Same Molecule, Different Approval

Approval attaches to an application supported by particular trials for a particular population and purpose, not to a chemical. Separate applications produce separate labeling, separate dosage ranges, separate safety sections and separate post-marketing obligations.

The practical consequence is coverage. A plan may cover one product containing tirzepatide and refuse another containing the same molecule for the same person, because it is applying the approved indication as its criterion.

Off-label prescribing remains lawful where a clinician judges it appropriate, but it does not alter approval status, does not create a coverage obligation, and does not mean the FDA reviewed evidence for that use.

Where Compounded Preparations Sit

They are not on the approved list, because they are not approved products. The FDA states that compounded drugs are not FDA-approved, meaning the agency does not verify their safety, effectiveness or quality before they are marketed.

The agency also states directly that compounded drugs and generic drugs are not the same: a generic is approved under section 505(j) and must establish therapeutic equivalence, while a compounded drug is not approved. No approved generic semaglutide or tirzepatide exists.

What compounding is, properly described, is preparation by a state-licensed pharmacy against a prescription for an individual patient whose medical need cannot be met by an approved drug. PlexusDx works only with licensed 503A compounding pharmacies.

How Your Genetics Relate to GLP-1 Pathways

Not everyone responds to GLP-1 medications the same way. Genetic variants — including GIPR rs1800437, FTO rs9939609, and MC4R rs17782313 — relate to the biological pathways these medications act on. These are pathway-level associations only and do not predict how much weight you will lose or how you will respond to any specific medication. PlexusDx maps 14 pathways, 49 peptides, and 150+ genetic insights so you and your provider can see how your genes relate to these pathways. It does not recommend, prescribe, or determine which medication, dose, or peptide is right for you. The PlexusDx Precision Peptide Genetic Test ($298) gives you and your provider pathway-level genetic context to support a more personalized conversation. Genetics is a guide, not a guarantee.

Access Personalized GLP-1 Care Through PlexusDx

PlexusDx offers seven prescription GLP-1 protocols to all 50 states — no membership, no insurance required, async intake or live consult. The Tirzepatide Injection is $289/mo month-to-month, or from $249/mo on the 6-month plan. Medications are dispensed from licensed 503A compounding pharmacies following strict quality and safety standards. Add a Precision Peptide Genetic Test for $298 to personalize your protocol from day one.

Frequently Asked Questions

Which GLP-1 drugs are FDA-approved for weight loss?

Wegovy (semaglutide injection and tablets), Zepbound (tirzepatide), Saxenda (liraglutide 3 mg) and Foundayo (orforglipron, approved April 1, 2026) carry chronic weight management indications. Ozempic, Mounjaro and Rybelsus do not — they are type 2 diabetes products, some with additional cardiovascular or kidney indications, but none with a weight-management claim.

Is Mounjaro approved for weight loss?

No. Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes, and that is its entire approved indication. Zepbound contains the same molecule, tirzepatide, and holds the chronic weight management indication plus a separate indication for moderate to severe obstructive sleep apnea in adults with obesity.

Are there approved oral options for weight loss?

Yes, two. Wegovy tablets were approved December 22, 2025 in 1.5, 4, 9 and 25 mg strengths, carrying the cardiovascular risk reduction and weight reduction indications. Foundayo (orforglipron) was approved April 1, 2026 as an oral small-molecule tablet for chronic weight management. There is no FDA-approved oral tirzepatide and no oral Zepbound.

Why can two products with the same drug have different approvals?

Because FDA approval attaches to an application supported by specific trials for a specific population and purpose, not to a molecule. Separate applications produce separate labeling, dosage ranges, safety sections and post-marketing obligations. Insurance plans key coverage to the approved indication, which is why one product may be covered and another with the identical ingredient refused.

Are compounded versions approved for weight loss?

No. The FDA states that compounded drugs are not FDA-approved and that it does not verify their safety, effectiveness or quality before marketing. The agency also states that compounded drugs and generic drugs are not the same, since a generic is approved under section 505(j) and must establish therapeutic equivalence. No approved generic semaglutide or tirzepatide exists.

Medical and Editorial Standards

Medical review process: This article was reviewed for medical accuracy, scientific clarity, evidence alignment, and appropriate discussion of genetics, medications, supplements, biomarkers, and health-related claims.

Sources and evidence: PlexusDx educational content is developed using peer-reviewed research, clinical literature, reputable medical references, and, where applicable, public health or regulatory guidance.

Commercial transparency: PlexusDx offers genetic testing, blood biomarker testing, personalized supplement recommendations, and related precision wellness services. Product mentions are intended to help readers understand available options and should not be interpreted as medical advice.

Important disclaimer: PlexusDx educational content is for informational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before making decisions about medications, supplements, genetic testing, lab testing, or health-related care.