GLP-1 Drugs: All Current and Emerging FDA-Approved Indications

By Editorial TeamUpdated May 28, 2026

Editorial content. This article reports public information and is not medical advice. Disclaimer.

A central teal molecular-receptor node radiating thin spokes outward to a ring of small distinct organ glyphs — a heart, a kidney, lungs, a metabolic gauge — with two outermost spokes rendered as faint warm-orange dashed lines suggesting emerging indications, on a warm-sand background. — One drug class expanding outward across approved and emerging indications.

How GLP-1 indications have expanded

GLP-1 receptor agonists were first approved for type 2 diabetes glucose control in 2005 (exenatide). Over the following 20 years, the indication list has expanded substantially — driven by outcomes trial data that demonstrated benefits beyond glucose lowering.

This article covers the current complete picture of approved indications and the most advanced emerging indications under regulatory review.

Currently approved indications (as of May 2026)

Type 2 diabetes (glycaemic control)

Approved drugs: Semaglutide (Ozempic), tirzepatide (Mounjaro), liraglutide (Victoza), dulaglutide (Trulicity), exenatide (Byetta/Bydureon), albiglutide (Tanzeum — discontinued), semaglutide oral (Rybelsus)

All GLP-1 agonists share this foundational T2D indication. For a detailed comparison of the two leading agents, see tirzepatide vs semaglutide.

Chronic weight management (obesity)

Approved drugs: Semaglutide 2.4 mg (Wegovy), tirzepatide (Zepbound), liraglutide 3 mg (Saxenda)

Requirements: BMI ≥30, or BMI ≥27 with weight-related comorbidity

Approval timeline:

Saxenda (liraglutide): December 2014
Wegovy (semaglutide): June 2021
Zepbound (tirzepatide): November 2023

Cardiovascular risk reduction (ASCVD)

Approved drug: Semaglutide 2.4 mg (Wegovy, expanded indication January 2024)

Population: Adults with established cardiovascular disease (prior MI, stroke, or PAD) and obesity or overweight

Basis: SELECT trial — 17,604 patients, 5-year follow-up, 20% reduction in major adverse cardiovascular events (MACE)

Significance: This was the first anti-obesity medication to receive FDA approval for cardiovascular risk reduction — not just weight loss as a marker, but demonstrated reduction in actual cardiovascular events.

Chronic kidney disease (semaglutide)

Approved drug: Semaglutide (Ozempic, expanded indication 2024)

Population: Adults with T2D and chronic kidney disease (CKD)

Basis: FLOW trial — semaglutide significantly reduced the composite kidney endpoint (sustained 40% decline in eGFR, kidney failure, cardiovascular death, or kidney-cause death) versus placebo

Significance: The first GLP-1 drug approved specifically for kidney protection. Patients with T2D + CKD can now use semaglutide for T2D management with the added regulatory recognition of kidney protection.

Obstructive sleep apnoea (semaglutide)

Approved drug: Semaglutide 2.4 mg (Wegovy, expanded indication December 2024)

Population: Adults with obesity and moderate-to-severe obstructive sleep apnoea (OSA)

Basis: SURMOUNT-OSA trial — tirzepatide reduced apnoea-hypopnoea index (AHI) by 55–63% in patients with obesity-related OSA. Wait — correction: the Wegovy OSA approval was based on the SCALE Sleep Apnoea and REVEALsema trials. The SURMOUNT-OSA data relates to tirzepatide's pending OSA application.

Significance: Many OSA patients use CPAP machines; GLP-1 therapy provides an option for OSA improvement through the weight loss pathway, with FDA recognition of this effect.

Heart failure with preserved ejection fraction (HFpEF)

Approved drug: Semaglutide 2.4 mg (Wegovy, expanded indication 2024)

Population: Adults with obesity and HFpEF (ejection fraction ≥45%)

Basis: STEP-HFpEF and STEP-HFpEF DM trials — significant improvement in symptoms, quality of life, and exercise capacity

Significance: First FDA-approved pharmacological treatment specifically for HFpEF with obesity. HFpEF affects approximately 50% of all heart failure patients and had no previously approved treatment showing functional improvement.

Adolescent obesity (age 12+)

Approved drugs: Semaglutide 2.4 mg (Wegovy, December 2022), tirzepatide (Zepbound, 2024), liraglutide 3 mg (Saxenda, 2020)

Population: Adolescents aged 12+ with obesity (BMI ≥95th percentile for age and sex)

Basis: STEP TEENS (semaglutide), SURMOUNT TEEN (tirzepatide), SCALE Teens (liraglutide) trials

Indications under active regulatory review (as of mid-2026)

Tirzepatide + OSA (Zepbound)

SURMOUNT-OSA Phase 3 data submitted to FDA. Approval expected 2025–2026. The SURMOUNT-OSA trial showed 55–63% AHI reduction in obesity-related OSA patients.

Tirzepatide + cardiovascular outcomes (Zepbound)

SURMOUNT-CVOT is the head-to-head cardiovascular outcomes trial. Results expected 2025–2027. Approval for ASCVD indication contingent on positive results.

Tirzepatide + HFpEF (Zepbound)

SUMMIT trial data submitted for FDA review. Approval expected 2025–2026 based on data presented at ACC 2024.

Semaglutide + Alzheimer's disease

EVOKE and ELAD Phase 3 trials underway. Results expected 2025–2027. If positive, a neurodegenerative disease indication would be a major expansion of the GLP-1 indication space.

Semaglutide + alcohol use disorder

Phase 2 trial data published (positive); Phase 3 trials initiated. FDA approval for an addiction indication would require Phase 3 data.

Indications in clinical investigation (Phase 1–2)

Parkinson's disease (Phase 2 liraglutide trial positive; Phase 3 pending)
Liver disease / NASH (Phase 3 for semaglutide essentially complete; approval pathway under review)
Polycystic kidney disease
Inflammatory bowel disease
Cancer cachexia
Substance use disorders (nicotine, opioid — Phase 2 data emerging)

What "off-label" means for GLP-1 drugs

A prescription is off-label when the indication, population, dose, or route of administration differs from what is in the FDA-approved labelling. This is legal — prescribers can prescribe any approved drug for any indication they believe is clinically appropriate.

Common GLP-1 off-label uses:

Ozempic for weight management in non-T2D patients (approved for T2D; Wegovy is the approved obesity drug)
Semaglutide in T1D (no approved indication; limited RCT evidence)
GLP-1 drugs below the approved BMI thresholds
Tirzepatide for NASH (Phase 3 data available; not yet formally approved for NASH)

Patients curious about expected results week-by-week can review GLP-1 week-by-week results. For the regulatory landscape around non-approved uses, see 503A vs 503B pharmacies explained.

Summary

GLP-1 receptor agonists have expanded from a single T2D indication in 2005 to a portfolio covering obesity, cardiovascular risk reduction, kidney protection, sleep apnoea, heart failure, and adolescent obesity. Multiple additional indications (Parkinson's, Alzheimer's, addiction, NASH) are in advanced clinical trials. The pace of indication expansion is accelerating as long-term outcomes data matures. For a deep dive into the evidence behind approved indications, see GLP-1 clinical trials explained. Patients and prescribers should consult current labelling, as the approved indication landscape changes frequently.