Scientific deep-dive
GLP-1 Medication List 2026: Every FDA-Approved & Investigational GLP-1 Drug in One Reference
The complete 2026 reference list of every FDA-approved GLP-1 receptor agonist (Wegovy, Zepbound, Foundayo, Saxenda, Ozempic, Mounjaro, Rybelsus, Trulicity, Victoza, Byetta status, Bydureon BCise status, Hikma generic liraglutide, Teva generic liraglutide, Amneal generic exenatide) plus the major investigational pipeline drugs (retatrutide, MariTide, CagriSema, survodutide, mazdutide, ecnoglutide, pemvidutide, petrelintide). For each: brand name + generic + manufacturer + indication + route + frequency + FDA approval date + DailyMed SetID.
- GLP-1
- Reference
- FDA-approved
- Investigational
- Drug list
- Patient guide
This is the canonical 2026 reference list of every GLP-1 receptor agonist medication a US patient or prescriber will encounter. Eleven branded GLP-1 RAs are FDA-approved on the US market — four for chronic weight management (Wegovy, Zepbound, Foundayo, Saxenda), five for type 2 diabetes (Ozempic, Mounjaro, Rybelsus, Trulicity, Victoza), and two for type 2 diabetes that were discontinued by AstraZeneca in October 2024 (Byetta and Bydureon BCise). Three generic GLP-1s are now FDA-approved (Hikma generic liraglutide referencing Victoza — December 2024, the FIRST generic GLP-1 RA in the US; Amneal generic exenatide referencing Byetta — November 21, 2024; Teva generic liraglutide 3 mg referencing Saxenda — August 28, 2025, the FIRST generic GLP-1 RA approved for chronic weight management). Eight investigational GLP-1-class drugs are in late-stage development without FDA approval as of May 2026 (retatrutide, MariTide, CagriSema, survodutide, mazdutide, ecnoglutide, pemvidutide, petrelintide). Every drug below is anchored to its verbatim DailyMed FDA-label SetID or to the manufacturer's registration trial PMID — no LLM paraphrase, no secondary source. The hard rules: brand-name vs generic, indication vs formulation, FDA-approved vs investigational, Trulicity-as-biologic-on-BLA, and DPP-4-inhibitors-are-NOT- GLP-1-RAs are called out at every layer where readers misclassify.
About this article
Every approval date and every dosing detail below was re-verified against the live DailyMed FDA label or against the FDA Drugs@FDA approval letter on 2026-05-09. China NMPA approvals (Innovent mazdutide, Sciwind ecnoglutide) do NOT predict FDA approval and do not place a drug on the US market. Discontinuation status for Byetta and Bydureon BCise is verbatim per AstraZeneca's October 2024 announcements. The investigational pipeline section reflects the latest publicly disclosed phase-3 program status as of May 2026 and will shift as readouts and NDA filings arrive. For brand-by-brand decision support see our brand-name cheat sheet and indication disambiguation guide.
FDA-approved GLP-1s for weight management (the short list)
Four GLP-1 receptor agonists are FDA-approved for chronic weight management on the US market in May 2026. Three are injectable (Wegovy, Zepbound, Saxenda); one is oral (Foundayo). All four carry the class-wide boxed warning for thyroid C-cell tumors based on rodent data, with the contraindication for personal or family history of medullary thyroid carcinoma (MTC) and Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Wegovy (semaglutide 2.4 mg)
- Brand name: Wegovy
- Active ingredient: Semaglutide
- Manufacturer: Novo Nordisk
- FDA-approved indication: Chronic weight management in adults with BMI ≥ 30 (obesity), or BMI ≥ 27 with at least one weight-related comorbidity. Pediatric extension to age 12+ added December 2022. Cardiovascular risk-reduction indication added March 2024 per the SELECT trial.
- Route + frequency: Subcutaneous injection, once weekly
- FDA approval date: June 4, 2021
- Dosing ladder: 0.25 mg → 0.5 mg → 1 mg → 1.7 mg → 2.4 mg (5 escalation steps, ≥4 weeks each). Wegovy HD 7.2 mg pen approved at higher dose in 2025.
- DailyMed SetID:
ee06186f-2aa3-4990-a760-757579d8f77b - Internal link: Wegovy drug page
Zepbound (tirzepatide)
- Brand name: Zepbound
- Active ingredient: Tirzepatide (dual GLP-1 + GIP receptor agonist)
- Manufacturer: Eli Lilly
- FDA-approved indication: Chronic weight management in adults with BMI ≥ 30 or BMI ≥ 27 with comorbidity. Obstructive sleep apnea (OSA) indication added December 2024 per the SURMOUNT-OSA trial — the only GLP-1 with an FDA-approved OSA indication.
- Route + frequency: Subcutaneous injection, once weekly
- FDA approval date: November 8, 2023
- Dosing ladder: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg (6 escalation steps, ≥4 weeks each)
- SURMOUNT-1 effect size (PMID 35658024): −20.9% body weight at 15 mg over 72 weeks vs −3.1% placebo
- DailyMed SetID:
487cd7e7-434c-4925-99fa-aa80b1cc776b - Internal link: Zepbound drug page
Foundayo (orforglipron)
- Brand name: Foundayo
- Active ingredient: Orforglipron — the FIRST non-peptide small-molecule GLP-1 receptor agonist
- Manufacturer: Eli Lilly
- FDA-approved indication: Chronic weight management in adults with BMI ≥ 30 or BMI ≥ 27 with comorbidity. Approved under FDA's National Priority Voucher Program.
- Route + frequency: Oral tablet, once daily — with or without food (no fasted-morning rule, no water cap)
- FDA approval date: April 1, 2026
- Dosing ladder: 0.8 mg → 2.5 mg → 5.5 mg → 9 mg → 14.5 mg → 17.2 mg (6 escalation steps, ≥30 days each)
- ATTAIN-1 effect size (PMID 40960239): −11.1% body weight at 17.2 mg over 72 weeks vs −2.1% placebo
- DailyMed SetID:
8ac446c5-feba-474f-a103-23facb9b5c62 - Internal link: Foundayo drug page
Saxenda (liraglutide 3 mg)
- Brand name: Saxenda
- Active ingredient: Liraglutide (3 mg weight-management dose)
- Manufacturer: Novo Nordisk
- FDA-approved indication: Chronic weight management in adults with BMI ≥ 30 or BMI ≥ 27 with comorbidity. Pediatric extension to age 12+ added December 2020.
- Route + frequency: Subcutaneous injection, once daily
- FDA approval date: December 23, 2014
- Dosing ladder: 0.6 mg → 1.2 mg → 1.8 mg → 2.4 mg → 3.0 mg (5 escalation steps, ≥7 days each)
- Generic status: Teva generic liraglutide 3 mg launched August 28, 2025 — the first generic GLP-1 RA approved for weight management. See “Generic GLP-1s” section below.
- DailyMed SetID:
3946d389-0926-4f77-a708-0acb8153b143
FDA-approved GLP-1s for type 2 diabetes (T2D-only)
Seven branded GLP-1 receptor agonists are FDA-approved for type 2 diabetes glycemic control, two of which were discontinued by AstraZeneca in October 2024. None of the T2D-indicated drugs is FDA-approved for chronic weight management — patients receiving Ozempic, Mounjaro, Rybelsus, Trulicity, or Victoza for weight loss are doing so off-label. (The cleaner FDA weight-management path is Wegovy, Zepbound, Foundayo, or Saxenda above; for the full disambiguation see our diabetes-vs-weight-loss medication disambiguation guide.)
Ozempic (semaglutide)
- Brand name: Ozempic
- Active ingredient: Semaglutide (same molecule as Wegovy and Rybelsus, different doses and formulation)
- Manufacturer: Novo Nordisk
- FDA-approved indication: Type 2 diabetes glycemic control. Cardiovascular risk reduction (MACE) in T2D adults with established CV disease added January 2020 per the SUSTAIN-6 trial. Chronic kidney disease progression-risk indication added January 2025 per the FLOW trial.
- Route + frequency: Subcutaneous injection, once weekly
- FDA approval date: December 5, 2017
- Dosing: 0.25 → 0.5 → 1 → 2 mg weekly (max FDA-approved Ozempic dose is 2 mg, vs Wegovy's 2.4 mg)
- DailyMed SetID:
adec4fd2-6858-4c99-91d4-531f5f2a2d79 - Internal link: Ozempic drug page
Mounjaro (tirzepatide)
- Brand name: Mounjaro
- Active ingredient: Tirzepatide (same molecule as Zepbound, dual GLP-1 + GIP receptor agonist)
- Manufacturer: Eli Lilly
- FDA-approved indication: Type 2 diabetes glycemic control only as of May 2026 (no MACE indication yet — SURPASS-CVOT cardiovascular outcomes trial in progress)
- Route + frequency: Subcutaneous injection, once weekly
- FDA approval date: May 13, 2022
- Dosing: 2.5 → 5 → 7.5 → 10 → 12.5 → 15 mg weekly (identical to Zepbound)
- DailyMed SetID:
d2d7da5d-ad07-4228-955f-cf7e355c8cc0 - Internal link: Mounjaro drug page
Rybelsus (oral semaglutide)
- Brand name: Rybelsus
- Active ingredient: Semaglutide (oral peptide formulation with SNAC absorption enhancer)
- Manufacturer: Novo Nordisk
- FDA-approved indication: Type 2 diabetes glycemic control. Cardiovascular risk-reduction indication added October 17, 2025 per the SOUL trial (limited to 7 mg + 14 mg doses). NOT FDA-approved for weight management.
- Route + frequency: Oral tablet, once daily — verbatim §2: take at least 30 minutes before the first food, beverage, or other oral medications of the day, with no more than 4 ounces of plain water (the strictest administration rule in the GLP-1 class)
- FDA approval date: September 20, 2019 — the FIRST FDA-approved oral GLP-1 receptor agonist
- Dosing: 3 mg (acclimation) → 7 mg → 14 mg → 25 mg per recent label expansion
- DailyMed SetID:
27f15fac-7d98-4114-a2ec-92494a91da98 - Internal link: full Rybelsus / Foundayo / Wegovy-oral comparison
Trulicity (dulaglutide)
- Brand name: Trulicity
- Active ingredient: Dulaglutide — an Fc-fusion biologic (modified GLP-1 peptide fused to a human IgG4 Fc fragment), NOT a small-molecule peptide
- Manufacturer: Eli Lilly
- FDA-approved indication: Type 2 diabetes glycemic control. Cardiovascular risk reduction in T2D adults with or without established CV disease added February 2020 per the REWIND trial. NOT FDA-approved for weight management.
- Route + frequency: Subcutaneous injection, once weekly (single-dose pen)
- FDA approval date: September 18, 2014
- Dosing: 0.75 → 1.5 → 3 → 4.5 mg weekly (max FDA-approved Trulicity dose is 4.5 mg)
- Regulatory pathway: BLA — Biologic License Application (NOT NDA). Trulicity is the only GLP-1 RA on the market filed as a biologic. This means the only post- loss-of-exclusivity competition pathway is a 351(k) biosimilar (much higher dossier cost than a small- molecule generic) — not an ANDA generic. As of 2026-05-09, no biosimilar dulaglutide is FDA-approved. See our GLP-1 generic timeline for the full BLA-vs-NDA explainer and our Trulicity weight-loss evidence review.
- DailyMed SetID:
463050bd-2b1c-40f5-b3c3-0a04bb433309
Victoza (liraglutide 1.8 mg max)
- Brand name: Victoza
- Active ingredient: Liraglutide (same molecule as Saxenda, lower-dose formulation for diabetes)
- Manufacturer: Novo Nordisk
- FDA-approved indication: Type 2 diabetes glycemic control. Cardiovascular risk reduction in T2D adults with established CV disease added August 2017 per the LEADER trial. Pediatric extension to age 10+ added June 2019. NOT FDA-approved for weight management.
- Route + frequency: Subcutaneous injection, once daily
- FDA approval date: January 25, 2010
- Dosing: 0.6 → 1.2 → 1.8 mg daily (max 1.8 mg for diabetes vs Saxenda's 3.0 mg for weight management)
- Generic status: Hikma generic liraglutide FDA-approved and launched December 2024 — the FIRST generic GLP-1 RA approved in the United States. See “Generic GLP-1s” section below.
- DailyMed SetID:
5a9ef4ea-c76a-4d34-a604-27c5b505f5a4
Byetta (exenatide twice-daily) — DISCONTINUED
- Brand name: Byetta
- Active ingredient: Exenatide (synthetically produced exendin-4, a 39-amino-acid peptide originally derived from Gila monster saliva)
- Manufacturer: AstraZeneca (formerly Amylin / Eli Lilly)
- FDA-approved indication: Type 2 diabetes glycemic control (no MACE indication; the EXSCEL CVOT trial was for Bydureon, not twice-daily Byetta). NOT FDA-approved for weight management. No boxed warning on the original Byetta label.
- Route + frequency: Subcutaneous injection, twice daily (within 60 minutes before morning and evening meals)
- FDA approval date: April 28, 2005 — the FIRST GLP-1 receptor agonist approved by the FDA
- Discontinuation status: DISCONTINUED by AstraZeneca on October 25, 2024. No longer available on US pharmacy shelves at the brand level. Generic exenatide (Amneal, FDA-approved November 21, 2024) remains theoretically the only path to exenatide twice-daily on the US market — see “Generic GLP-1s” section.
- DailyMed SetID:
53d03c03-ebf7-418d-88a8-533eabd2ee4f
Bydureon BCise (exenatide extended-release) — DISCONTINUED
- Brand name: Bydureon BCise (the BCise autoinjector device replaced the original Bydureon single-use vial-and-syringe in 2017)
- Active ingredient: Exenatide extended- release (microsphere depot formulation that releases exenatide gradually over a week)
- Manufacturer: AstraZeneca
- FDA-approved indication: Type 2 diabetes glycemic control. Pediatric extension to age 10+ added July 2021. The EXSCEL CVOT trial showed CV safety but did not meet the bar for a positive MACE indication. NOT FDA-approved for weight management.
- Route + frequency: Subcutaneous injection, once weekly (autoinjector)
- FDA approval date: October 20, 2017 (BCise device); original Bydureon single-use formulation January 27, 2012
- Discontinuation status: DISCONTINUED by AstraZeneca on October 28, 2024. No biosimilar approved (the microsphere-plus- autoinjector combination is sufficiently complex that no biosimilar/generic pathway has been pursued).
- DailyMed SetID:
2d18cfc4-e0de-4814-a712-c1b7c504bff5
Generic GLP-1s now FDA-approved (2024-2025)
Three generic GLP-1 receptor agonists have FDA approval as of 2026-05-09 — every one of them via the small- molecule ANDA pathway, and every one of them for liraglutide or exenatide. No generic semaglutide, no generic tirzepatide, no generic orforglipron, and no biosimilar dulaglutide is FDA-approved as of May 2026. For the loss-of-exclusivity calendar across the rest of the class — including why Trulicity will need a 351(k) biosimilar rather than an ANDA generic — see our GLP-1 generic timeline and Zepbound generic / biosimilar timeline.
Hikma generic liraglutide (Victoza reference)
- Reference brand: Victoza
- Active ingredient: Liraglutide
- Indication: Type 2 diabetes glycemic control (Victoza-equivalent). Pediatric extension to age 10+. NOT for weight management.
- Manufacturer: Hikma Pharmaceuticals
- FDA approval date: December 23, 2024
- Significance: The FIRST generic GLP-1 receptor agonist approved in the United States. Confirmed by FDA news release on December 23, 2024.
- Route + frequency: Subcutaneous injection, once daily (matching Victoza)
Teva generic liraglutide 3 mg (Saxenda reference)
- Reference brand: Saxenda
- Active ingredient: Liraglutide 3 mg
- Indication: Chronic weight management (Saxenda-equivalent), adults with BMI ≥ 30 or BMI ≥ 27 with comorbidity. Pediatric extension to age 12+.
- Manufacturer: Teva Pharmaceuticals
- FDA launch date: August 28, 2025
- Significance: The FIRST generic GLP-1 receptor agonist approved for chronic weight management. First competitive pricing pressure on the weight- management GLP-1 segment.
- Route + frequency: Subcutaneous injection, once daily (matching Saxenda)
Amneal generic exenatide (Byetta reference)
- Reference brand: Byetta (twice-daily exenatide)
- Active ingredient: Exenatide
- Indication: Type 2 diabetes glycemic control (Byetta-equivalent). NOT for weight management.
- Manufacturer: Amneal Pharmaceuticals
- FDA approval date: November 21, 2024
- Significance: Approved approximately one month before AstraZeneca's October 25 / 28 discontinuation of Byetta + Bydureon BCise was fully felt at retail pharmacies. With the brand discontinued, generic exenatide is theoretically the only twice-daily exenatide path remaining on the US market — but real-world channel availability has been limited. Most clinicians have transitioned T2D patients off of exenatide entirely to once-weekly tirzepatide or semaglutide.
- Route + frequency: Subcutaneous injection, twice daily (matching Byetta)
Investigational pipeline (NOT yet FDA-approved)
Eight late-stage investigational GLP-1-class drugs are in Phase 2 or Phase 3 development as of May 2026. None of them is FDA-approved. None of them is legally available through compounding pharmacies (compounded “retatrutide” or “survodutide” offered by telehealth providers is a major regulatory red flag — see our FDA warning letters investigation). For the deeper trial-by-trial pipeline review see our pipeline deep-dive.
Retatrutide (Eli Lilly LY3437943)
- Mechanism: Triple agonist — GIP + GLP-1 + glucagon receptors
- Manufacturer: Eli Lilly
- Route + frequency: Subcutaneous injection, once weekly (in trials)
- Status: Phase 3 TRIUMPH program in progress (TRIUMPH-1, TRIUMPH-2, TRIUMPH-3, TRIUMPH-4, TRIUMPH-Outcomes). NDA NOT yet filed. NOT FDA-approved.
- Phase 2 effect size (Jastreboff et al., NEJM 2023): −24.2% body weight at 12 mg over 48 weeks (placebo-adjusted) — the largest weight- loss number ever reported in a Phase 2 obesity trial.
- Internal link: full retatrutide evidence review
MariTide / maridebart cafraglutide (Amgen)
- Mechanism: GIP receptor antagonist conjugated to a GLP-1 receptor agonist peptide via an antibody fragment (long-acting peptide-antibody conjugate)
- Manufacturer: Amgen
- Route + frequency: Subcutaneous injection, once monthly (in trials) — the major differentiator if it reaches market
- Status: Phase 3 MARITIME-1 and MARITIME-2 in progress (primary completion 2027-01-21 per ClinicalTrials.gov). NOT FDA-approved.
- Notable: Mechanism is unusual — pairs GIP antagonism with GLP-1 agonism, which is the opposite combination from tirzepatide's GIP+GLP-1 dual agonism.
CagriSema (Novo Nordisk)
- Mechanism: Fixed-ratio combination of semaglutide (GLP-1 RA) plus cagrilintide (long-acting amylin analog)
- Manufacturer: Novo Nordisk
- Route + frequency: Subcutaneous injection, once weekly (in trials)
- Status: Phase 3 REDEFINE-1, REDEFINE-2, REDEFINE-11 program; REDEFINE-1 topline (December 2024) showed −22.7% body weight at 68 weeks vs −16.1% for semaglutide alone — smaller incremental benefit than investor expectations had set. NDA timing not yet announced. NOT FDA-approved.
Survodutide (Boehringer Ingelheim + Zealand Pharma)
- Mechanism: Dual GLP-1 + glucagon receptor agonist
- Manufacturer: Boehringer Ingelheim (lead), Zealand Pharma (originator)
- Route + frequency: Subcutaneous injection, once weekly (in trials)
- Status: Phase 3 SYNCHRONIZE-1 trial completed in December 2025 (topline pending publication as of May 2026). FDA Fast Track designation for MASH. NOT FDA-approved.
Mazdutide (Innovent / Lilly)
- Mechanism: Dual glucagon + GLP-1 receptor agonist
- Manufacturer: Innovent Biologics (lead in China), licensed from Eli Lilly
- Route + frequency: Subcutaneous injection, once weekly
- Status: China NMPA-approved June 2025 for chronic weight management; no FDA filing. NOT FDA-approved. NMPA approval does not predict FDA approval — different regulatory standards, different bridging-trial requirements, and Innovent has not announced a US development plan.
Ecnoglutide (Sciwind XW003)
- Mechanism: GLP-1 receptor agonist (cAMP-biased signaling) — long-acting peptide
- Manufacturer: Sciwind Biosciences (commercialization partner Pfizer in Asia)
- Route + frequency: Subcutaneous injection, once weekly
- Status: China NMPA-approved March 2026 for chronic weight management; no FDA filing or US development plan announced. NOT FDA-approved.
Pemvidutide (Altimmune)
- Mechanism: Dual GLP-1 + glucagon receptor agonist
- Manufacturer: Altimmune
- Route + frequency: Subcutaneous injection, once weekly (in trials)
- Status: Phase 2 MOMENTUM trial topline showed −15.6% body weight at 1.8 mg over 48 weeks. FDA Fast Track designation for MASH. Phase 2b IMPACT trial in MASH ongoing. NOT FDA-approved.
Petrelintide (Zealand Pharma / Roche)
- Mechanism: Long-acting amylin analog (NOT a pure GLP-1 RA — included here because it's frequently grouped with the GLP-1 pipeline in patient searches and is part of the cagrilintide-class amylin family)
- Manufacturer: Zealand Pharma (originator), Roche (commercialization partner)
- Route + frequency: Subcutaneous injection, once weekly (in trials)
- Status: Phase 2 ZUPREME-1 trial completed. Phase 3 program planned. NOT FDA-approved.
Quick-reference table: every drug, every detail
Every FDA-approved branded GLP-1 RA on the US market and every FDA-approved generic — manufacturer, indication, route, frequency, FDA approval date, and DailyMed SetID for the verbatim FDA label. Investigational drugs are listed in the section above with the explicit NOT FDA-approved tag.
| Brand | Generic | Manufacturer | Indication | Route / Frequency | FDA approval | DailyMed SetID |
|---|---|---|---|---|---|---|
| Wegovy | Semaglutide 2.4 mg | Novo Nordisk | Weight management + CV (SELECT) | SC weekly | Jun 4, 2021 | ee06186f |
| Zepbound | Tirzepatide | Eli Lilly | Weight management + OSA | SC weekly | Nov 8, 2023 | 487cd7e7 |
| Foundayo | Orforglipron | Eli Lilly | Weight management | PO daily, no food restriction | Apr 1, 2026 | 8ac446c5 |
| Saxenda | Liraglutide 3 mg | Novo Nordisk | Weight management | SC daily | Dec 23, 2014 | 3946d389 |
| Ozempic | Semaglutide | Novo Nordisk | T2D + MACE + CKD | SC weekly | Dec 5, 2017 | adec4fd2 |
| Mounjaro | Tirzepatide | Eli Lilly | T2D only (no MACE indication yet) | SC weekly | May 13, 2022 | d2d7da5d |
| Rybelsus | Semaglutide (oral) | Novo Nordisk | T2D + MACE (7/14 mg per SOUL) | PO daily, strict 30-min fast | Sep 20, 2019 | 27f15fac |
| Trulicity | Dulaglutide | Eli Lilly | T2D + MACE (REWIND) | SC weekly (Fc-fusion biologic — BLA, not NDA) | Sep 18, 2014 | 463050bd |
| Victoza | Liraglutide 1.8 mg max | Novo Nordisk | T2D + MACE (LEADER) | SC daily | Jan 25, 2010 | 5a9ef4ea |
| Byetta | Exenatide | AstraZeneca | T2D — DISCONTINUED Oct 25, 2024 | SC twice-daily | Apr 28, 2005 | 53d03c03 |
| Bydureon BCise | Exenatide ER | AstraZeneca | T2D — DISCONTINUED Oct 28, 2024 | SC weekly | Oct 20, 2017 (BCise) | 2d18cfc4 |
| FDA-approved generic GLP-1s | ||||||
| Generic liraglutide (Hikma) | Liraglutide | Hikma | T2D (Victoza-equivalent) — FIRST generic GLP-1 RA | SC daily | Dec 23, 2024 | — |
| Generic exenatide (Amneal) | Exenatide | Amneal | T2D (Byetta-equivalent) | SC twice-daily | Nov 21, 2024 | — |
| Generic liraglutide (Teva) | Liraglutide 3 mg | Teva | Weight management (Saxenda-equivalent) — FIRST generic GLP-1 RA for weight management | SC daily | Aug 28, 2025 | — |
DailyMed SetID column shows the first 8 hex characters; full SetIDs are listed in the per-drug sections above and in the References block at the bottom of this page.
Indication-vs-formulation matrix
The most common patient question we see in search behavior is “is X approved for weight loss?” — usually about Ozempic, Mounjaro, Rybelsus, or Trulicity. The clean answer below clarifies which FDA-approved GLP-1 maps to which indication. Off-label prescribing of a T2D- indicated GLP-1 for weight management is legal but is not FDA-approved use, and insurance coverage typically follows the labeled indication.
| Drug | Weight management | Type 2 diabetes | Cardiovascular (MACE) | Other indications |
|---|---|---|---|---|
| Wegovy | FDA-approved | — | FDA-approved (SELECT, 2024) | — |
| Zepbound | FDA-approved | — | — | OSA (SURMOUNT-OSA, 2024) |
| Foundayo | FDA-approved | — | — | — |
| Saxenda | FDA-approved | — | — | — |
| Ozempic | — | FDA-approved | FDA-approved (SUSTAIN-6, 2020) | CKD (FLOW, 2025) |
| Mounjaro | — | FDA-approved | — | — |
| Rybelsus | — | FDA-approved | FDA-approved 7/14 mg (SOUL, 2025) | — |
| Trulicity | — | FDA-approved | FDA-approved (REWIND, 2020) | — |
| Victoza | — | FDA-approved | FDA-approved (LEADER, 2017) | Pediatric T2D ≥10 yr (2019) |
| Byetta | — | Was approved; DISCONTINUED Oct 2024 | — | — |
| Bydureon BCise | — | Was approved; DISCONTINUED Oct 2024 | — | Pediatric T2D ≥10 yr (2021) |
For the prescriber-decision view of which drug maps to which patient profile, see our diabetes-vs-weight-loss disambiguation guide and brand-name cheat sheet.
Why some GLP-1s are biologics and others aren't
This distinction matters for two reasons that almost no patient-facing resource explains: (1) regulatory pathway determines generic timing, and (2) biologic dossier means biosimilar, not generic, which materially changes the likely 2026-2030 pricing landscape.
Trulicity is a biologic (BLA pathway)
Dulaglutide is structurally an Fc-fusion biologic — the GLP-1 peptide sequence is fused to a human IgG4 Fc fragment that extends the half-life sufficiently for once-weekly dosing. Because it is a biologic, Trulicity was filed with the FDA under a Biologic License Application (BLA), not a New Drug Application (NDA). The post-loss-of-exclusivity competitive pathway is therefore a 351(k) biosimilar — a separate FDA pathway from ANDA generic, with substantially higher dossier costs (typically $100M+ versus $5-20M for an ANDA), longer clearance times, and fewer manufacturers willing to invest. As of 2026-05-09, no biosimilar dulaglutide is FDA- approved. See our GLP-1 generic timeline for the BLA-vs-NDA explainer in full.
Every other branded GLP-1 is a peptide (NDA pathway)
Wegovy, Zepbound, Foundayo, Saxenda, Ozempic, Mounjaro, Rybelsus, Victoza, Byetta, and Bydureon BCise were all filed with the FDA under New Drug Applications (NDAs) — small-molecule (or peptide-classed-as-small-molecule) regulatory dossiers. The post-LOE pathway is the small- molecule ANDA generic, which is what the Hikma, Teva, and Amneal generic approvals walked through. Foundayo (orforglipron) is an actual non-peptide small molecule, distinguishing it from semaglutide and tirzepatide which are peptides filed under the small- molecule NDA pathway by historical convention.
What's NOT on this list (and why)
Three classes of drug are commonly searched alongside GLP-1s but are not GLP-1 receptor agonists. Including them on a GLP-1 medication list would be incorrect.
DPP-4 inhibitors are NOT GLP-1 RAs
Dipeptidyl peptidase-4 (DPP-4) inhibitors — sitagliptin (Januvia), linagliptin (Tradjenta), saxagliptin (Onglyza), and alogliptin (Nesina) — are oral T2D drugs that prevent the breakdown of endogenous GLP-1 (and GIP), modestly raising circulating GLP-1 levels. They do not bind the GLP-1 receptor. The clinical effect is much smaller than a true GLP-1 RA: HbA1c reductions of around 0.5-0.8% with DPP-4 vs 1.5-2.0% with GLP-1 RA, and essentially no weight effect with DPP-4. DPP-4 inhibitors have their own pharmacology, generic landscape, and CV trial history (e.g., TECOS for sitagliptin) — none of which is interchangeable with the GLP-1 RA evidence base.
SGLT2 inhibitors are NOT GLP-1 RAs
Sodium-glucose cotransporter 2 (SGLT2) inhibitors — empagliflozin (Jardiance), dapagliflozin (Farxiga), canagliflozin (Invokana), ertugliflozin (Steglatro), and bexagliflozin (Brenzavvy) — block renal glucose reabsorption. They are an entirely different drug class with a different mechanism (renal excretion of glucose), different cardiovascular outcomes profile (heart failure + CKD reduction in EMPEROR-Reduced, DAPA-HF, DAPA-CKD), and different side-effect concerns (genital mycotic infections, euglycemic DKA). For the head-to-head comparison see our SGLT2-inhibitors-vs-GLP-1 deep-dive.
Grey-market “research peptides” are NOT FDA-approved
Patient searches occasionally surface grey-market sources of retatrutide, MariTide, survodutide, ecnoglutide, or other investigational GLP-1-class compounds sold as “research peptides” or by overseas pharmacies. None of these is FDA-approved. Compounding pharmacies cannot legally compound an investigational drug unless it is on an FDA bulk substances list — none of the pipeline drugs is. Buying or self-administering these products outside a clinical trial is illegal in the US and carries unverified-purity, unverified-potency, and unverified-contamination risk. See our FDA warning letters investigation for documented enforcement actions against telehealth providers offering compounded retatrutide and similar investigational products.
Bottom line
Eleven branded GLP-1 receptor agonists are FDA-approved on the US market in May 2026 (with two — Byetta and Bydureon BCise — discontinued by AstraZeneca in October 2024). Three generic GLP-1s are FDA-approved (Hikma generic liraglutide, Amneal generic exenatide, and the watershed Teva generic liraglutide 3 mg for weight management — the first generic GLP-1 RA approved for weight loss). Eight investigational pipeline drugs are in late-stage development without FDA approval. The cleanest reference for any clinical decision is the verbatim DailyMed FDA label via the SetIDs in the table above, plus the registration trial PMID and the prescriber-conversation framing in our brand-name cheat sheet and Foundayo vs Wegovy vs Zepbound comparison. This list will be updated as Rybelsus indications expand, as the investigational pipeline produces NDA filings, and as additional generics and biosimilars are approved.
Related research
- Weight loss injections guide 2026 — every FDA-approved injectable, effectiveness, cost, safety
- Wegovy / Ozempic / Zepbound / Mounjaro brand-name cheat sheet
- Foundayo vs Wegovy vs Zepbound full comparison
- GLP-1 pills 2026: Rybelsus / Foundayo / Wegovy-oral comparison
- GLP-1 pipeline (survodutide / MariTide / ecnoglutide)
- GLP-1 generic timeline + BLA-vs-NDA explainer
- Zepbound / tirzepatide generic + biosimilar timeline
- Diabetes vs weight-loss GLP-1 disambiguation
- Trulicity (dulaglutide) weight-loss evidence
- Retatrutide triple-agonist evidence review
- Illinois Medicaid GLP-1 coverage (2026): the strictest-exclusion state case study — doubly-anchored on 89 IAC § 140.441(b) + HFS PDL absence, no weight-management carve-back-in
- Georgia Medicaid GLP-1 coverage (2026): dual-level operational non-coverage — Statewide PDL omission + Peach State Health Plan explicit “Drugs prescribed for weight loss” Member PDL exclusion, pediatric-only Saxenda/Xenical PA gate, no MACE or MASH carve-back-in pathway
- North Carolina Medicaid GLP-1 coverage (2026): the double-reversal state — covered (Aug 2024) → terminated (Oct 2025) → reinstated (Dec 2025); Wegovy Preferred for chronic weight management — the only Preferred-status weight-management GLP-1 listing in the 9-state series
- Michigan Medicaid GLP-1 coverage (2026): partial retainment with morbid-obesity gate (BMI ≥ 40) + bariatric-surgery-avoidance prescriber attestation — Pattern #10 in the 50-state Medicaid series, first state to retain a weight-management pathway while raising the BMI floor by 10 points and imposing a uniquely Michigan prescriber attestation found in no other state
- SGLT2 inhibitors vs GLP-1 (different class — see why)
References
- 1.Novo Nordisk Inc. WEGOVY (semaglutide) injection, for subcutaneous use — US Prescribing Information. DailyMed (NIH). 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
- 2.Eli Lilly and Company. ZEPBOUND (tirzepatide) injection, for subcutaneous use — US Prescribing Information. DailyMed (NIH). 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b
- 3.Eli Lilly and Company. FOUNDAYO (orforglipron) tablets, for oral use — US Prescribing Information. DailyMed (NIH). 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ac446c5-feba-474f-a103-23facb9b5c62
- 4.Novo Nordisk Inc. SAXENDA (liraglutide) injection, for subcutaneous use — US Prescribing Information. DailyMed (NIH). 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143
- 5.Novo Nordisk Inc. RYBELSUS (semaglutide) tablets, for oral use — US Prescribing Information. DailyMed (NIH). 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98
- 6.Eli Lilly and Company. TRULICITY (dulaglutide) injection, for subcutaneous use — US Prescribing Information. DailyMed (NIH). 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309
- 7.U.S. Food and Drug Administration. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes (Hikma generic liraglutide). FDA News Release. 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes
- 8.Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). N Engl J Med. 2022. PMID: 35658024.
Glossary references
Key terms in this article, linked to their canonical definitions.
- Wegovy · Drugs and brands
- Ozempic · Drugs and brands
- Zepbound · Drugs and brands
- Mounjaro · Drugs and brands
- Rybelsus · Drugs and brands
- Foundayo · Drugs and brands
- Saxenda · Drugs and brands
- Semaglutide · Drugs and brands
- Tirzepatide · Drugs and brands
- Orforglipron · Drugs and brands
- GLP-1 receptor · Mechanism
- GIP receptor · Mechanism
- Dual agonist · Mechanism
- Retatrutide · Drugs and brands
- CagriSema · Drugs and brands
- Survodutide · Drugs and brands
- MariTide (Maridebart Cafraglutide) · Drugs and brands
- Ecnoglutide · Drugs and brands