Data updated: May 26, 2026
ZEPBOUND (tirzepatide)
G-Protein-linked Receptor Interactions Genetically Validated
Metabolic
Approved 2023-11-08
Zepbound helps adults with obesity or those who are overweight with at least one weight-related health issue lose excess weight and maintain that loss over time. When used alongside a reduced-calorie diet and increased exercise, it also treats moderate to severe obstructive sleep apnea in patients with obesity. This medication is not recommended for use with other products containing tirzepatide or any GLP-1 receptor agonists.
How ZEPBOUND Works
This medication works by binding to and activating both GIP and GLP-1 receptors, which are found in areas of the brain that regulate appetite and caloric intake. By activating neurons in these regions, it helps control food intake and regulate how much a person eats. It also includes a fatty diacid component that allows it to bind to albumin, which extends how long the drug stays active in the body.
3
Indications
--
Phase 3 Trials
2
Priority Reviews
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-11-08
- Patent Cliff
- 2036
- Revenue
- $4.2B (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
ZEPBOUND Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
156 FDA actions from 2023 to 2026 · 2 indication expansions
What ZEPBOUND Treats
3 indicationsZEPBOUND is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obesity
- Overweight
- Obstructive Sleep Apnea
Source: FDA Label
ZEPBOUND Boxed Warning
RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. ZEPBOUND is contraindicated in patients with a pers...
WARNING: RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).
ZEPBOUND Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
ZEPBOUND Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
1
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
10
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 16 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZEPBOUND's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZEPBOUND treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZEPBOUND
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
MOUNJARO (AUTOINJECTOR)
TIRZEPATIDE
Eli Lilly
Shared indications:
ObesityObstructive Sleep Apnea
📋
Clinical Trial Registry
151 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06965413 GYMINDA | BC45538 2024-519561-22-00 | Ph 2 | active not recruiting | A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity |
| NCT07559500 | 10002447 002447-AA | Ph 1 | recruiting | Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD) |
| NCT06588296 TOGETHER-PsA | 27241 I1F-MC-RHDB | Ph 3 | completed | Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight |
| NCT06937086 COMMIT-UC | 27280 2024-520209-38-00, I6T-MC-AMCD | Ph 3 | recruiting | Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study |
| NCT06937099 COMMIT-CD | 27281 2024-520210-21-00, I6T-MC-AMCE | Ph 3 | recruiting | Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight |
| NCT06914895 SURPASS-T1D-1 | 27285 I8F-MC-GPJA, 2024-519684-17-00 | Ph 3 | active not recruiting | A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight |
| NCT06439277 | 18832 I8F-MC-GPIX | Ph 3 | recruiting | A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) |
| NCT07438444 | 27235 I8F-IN-GPIZ | Ph 4 | recruiting | A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity |
| NCT05536804 TREASURE-CKD | 17217 I8F-MC-GPIG, 2021-005273-47 | Ph 2 | active not recruiting | A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes |
| NCT07573163 | STUDY25030073 | Ph 2 | not yet recruiting | Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion |
| NCT07298915 EXER-MED | 302929 | Ph 3 | not yet recruiting | The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) |
| NCT06373146 | 18750 I8F-MC-GPIV | Ph 2 | completed | A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity |
| NCT06534411 REIMAGINE 5 | NN9388-7741 U1111-1300-2590, 2023-509600-15 | Ph 3 | active not recruiting | A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both |
| NCT07554638 | AAAV9609 | Ph 4 | not yet recruiting | Incretin Therapies in Obesity-related HFpEF |
| NCT07555730 | Lifestyle, Tirzepatide in T2D | Ph 4 | not yet recruiting | AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN) |
| NCT07228741 | RESIST NCI-2026-00106 | Ph 2 | recruiting | Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity |
| NCT06700538 | AROINHBE-1001 | Ph 1, Ph 2 | recruiting | A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus |
| NCT06221969 | NN9388-4894 U1111-1282-5561, 2023-503789-21-00 | Ph 3 | completed | A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor |
| NCT06143956 | 18685 W8M-MC-CWMM, W8M-MC-OXA1 | Ph 2 | recruiting | A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight |
| NCT06657209 | 77199 | Ph 4 | recruiting | Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide |
| NCT07096908 | RA HM-2025-03 | Ph 4 | recruiting | Tirzepatide Use in People With Obesity and Type 1 Diabetes |
| NCT07247084 | 27331 I8F-MC-GPJF | Ph 4 | recruiting | A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK) |
| NCT07165028 | 27610 2025-522674-36-00, N1T-MC-MALO | Ph 3 | recruiting | A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) |
| NCT06857942 | 27319 I1F-MC-RHDD | Ph 4 | recruiting | A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO) |
| NCT07299084 | 27358 I8F-MC-GPJE | Ph 1 | active not recruiting | A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus |
| NCT07154719 GRAMS | PBRC 2024-031 | Ph 4 | recruiting | GLP-1R Actions on Muscle and the Skeleton |
| NCT06326060 | NN9541-5015 U1111-1291-9210, jRCT2051230198 | Ph 2 | completed | A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight |
| NCT06811324 | STUDY00001208 | Ph 2 | recruiting | Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults |
| NCT07527910 | ALN-PNP-MASLD-2543 | Ph 2 | not yet recruiting | A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD |
| NCT06662383 TRIUMPH-5 | 18585 J1I-MC-GZBP, 2024-511450-49-00 | Ph 3 | active not recruiting | A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity |
| NCT07521631 | HDM1005-203 | Ph 2 | recruiting | Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes |
| NCT07349641 | NCI-2026-00081 NCI-2026-00081, MDA24-19-01 | Ph 2 | not yet recruiting | A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer |
| NCT07046819 | 10002246 002246-AA | Ph 2 | recruiting | Tirzepatide in MetALD |
| NCT06803888 | 24-915 | Ph 4 | active not recruiting | Bariatric Surgery vs. Semaglutide vs. Tirzepatide |
| NCT06774079 | 20240982 | Ph 4 | recruiting | Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients |
| NCT05933499 | 2023P001334 | Ph 2 | recruiting | Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity |
| NCT06732245 | NA-931-200 | Ph 2 | not yet recruiting | Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese |
| NCT06047548 | 18720 I8F-MC-GPIQ | Ph 3 | completed | A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities |
| NCT06651177 TAB | 2024-1003 UG1DA013732 | Ph 2 | recruiting | Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder |
| NCT07220473 | 25-0169 | Ph 2 | recruiting | Tirzepatide to Slow Biological Aging |
| NCT07218445 | 25-001692 | Ph 4 | recruiting | The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity |
| NCT06037252 | 18739 I8F-MC-GPIT, 2023-504561-24-00 | Ph 2 | active not recruiting | A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity |
| NCT07481747 SURMOUNT-1 | I8F-MC-GPHK(b) | Ph 3 | recruiting | Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1) |
| NCT07483801 DECODE | DECODE (A097165) | Ph 4 | not yet recruiting | DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies |
| NCT07257484 | 25-06029016 KL2TR002385 | Ph 4 | not yet recruiting | Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors |
| NCT07468552 | NIDA/VA CS #1037 | Ph 2 | not yet recruiting | Trial of Tirzepatide for the Treatment of Cannabis Use Disorder |
| NCT07463846 | ALN-2232-001 | Ph 1, Ph 2 | recruiting | A Study to Evaluate ALN-2232 in Participants With Obesity |
| NCT06246799 | STUDY00000139 R01DK097554 | Ph 3 | recruiting | Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes |
| NCT06162715 GRABS-0 | VR72411 | Ph 2, Ph 3 | enrolling by invitation | GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial |
| NCT07095517 PROSPECT | 25-460 1OT2CA297680-01, CGCATF-2023/100036 | Ph 1 | recruiting | Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors |
Showing 50 of 151 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZEPBOUND FDA Label Details
Indications & Usage
FDA Label (PDF)ZEPBOUND is indicated for the treatment of Obesity; Overweight; Obstructive Sleep Apnea.
⚠️ BOXED WARNING
WARNING: RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human rele...
View full patent landscape →
6 OB patents · 4 families ·
261 international docs across 47 countries
ZEPBOUND Patents & Exclusivity
Latest Patent: Jul 2039
Exclusivity: Dec 2027
Patents (6 active)
US12343382
Expires Jul 22, 2039
US12453758
Expires Jul 22, 2039
US11918623
Expires Jun 14, 2039
US11357820
Expires Jun 14, 2039
US12453756
Expires Jun 14, 2039
US9474780
Expires Jan 5, 2036
Exclusivity
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NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
NP
Until Nov 2026
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
I-958
Until Dec 2027
M-82
Until Oct 2027
NCE
Until May 2027
Source: FDA Orange Book
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