Zepbound
Zepbound is Eli Lilly’s tirzepatide product for obesity-related indications in the United States. Its label covers long-term weight reduction and maintenance in a defined adult population and moderate-to-severe obstructive sleep apnea in adults with obesity. Zepbound is not another name for tirzepatide generally, and its label should not be transferred to Mounjaro or other incretin products.
The US record reviewed here is current to July 23, 2026. The current DailyMed prescribing information should be checked before reusing indication, population, presentation, dose, safety, or availability claims.
Reference record
Section titled “Reference record”| Field | Zepbound record |
|---|---|
| Entity type | Prescription drug product and brand |
| Active ingredient | Tirzepatide |
| Drug class | GIP/GLP-1 receptor agonist |
| Principal company | Eli Lilly |
| US route | Subcutaneous injection |
| US application | NDA 217806 |
| Initial Zepbound approval | November 8, 2023 |
| Major clinical program | SURMOUNT |
Product identity
Section titled “Product identity”Zepbound is a product-level record. Tirzepatide is its active ingredient, while the Zepbound brand, presentations, strengths, indications, and application history belong to the product record.
Tirzepatide also appears in Mounjaro. FDA initially approved Mounjaro in 2022 for a type 2 diabetes indication, while Zepbound received its original approval in 2023 for an obesity-related weight-reduction indication. Shared ingredient identity does not make the two brands, labels, commercial channels, or covered uses interchangeable.
Current US label scope
Section titled “Current US label scope”The current label contains two indication areas.
| Label area | Current Zepbound scope |
|---|---|
| Long-term weight reduction and maintenance | Adults with obesity, or adults with overweight and at least one weight-related comorbid condition |
| Obstructive sleep apnea | Moderate-to-severe obstructive sleep apnea in adults with obesity |
| Pediatric use | Safety and effectiveness have not been established in pediatric patients |
| Route | Subcutaneous injection |
Both indications appear in combination with reduced-calorie diet and increased physical activity in the label. This wording identifies the approved-use context; it is not individualized treatment guidance.
The obstructive-sleep-apnea indication is narrower than a general sleep-apnea claim. It is limited by OSA severity, adult population, obesity status, and the product-specific US label.
Presentations and strengths
Section titled “Presentations and strengths”The April 2026 US label describes several delivery presentations under the same Zepbound product record.
| Presentation | Product context |
|---|---|
| Single-dose prefilled pen | One labeled dose in a prefilled injection device |
| Single-dose vial | One labeled dose supplied in a vial |
| Multi-dose vial | Four weekly doses in one vial |
| Single-patient-use KwikPen | Four fixed weekly doses in one prefilled pen |
The labeled strengths span 2.5 mg through 15 mg, but initiation, escalation, maintenance, and indication-specific dosing remain distinct label fields. The existence of a strength or presentation does not establish that it is a maintenance dose, appropriate for every indication, stocked locally, covered by insurance, or interchangeable with another delivery device.
Company and application roles
Section titled “Company and application roles”Eli Lilly developed and commercializes Zepbound. FDA’s approval notice says the original approval was granted to Eli Lilly and Company, while the current label identifies Lilly USA, LLC as the US marketer.
| Record | Role captured |
|---|---|
| NDA 217806 | Original and supplemental US regulatory record for Zepbound |
| FDA approval notices | Dated approval and indication-expansion context |
| Current DailyMed label | Product-specific labeling, presentation, packager, and marketing information |
| Lilly commercial disclosures | Dated channel, launch, and presentation context |
These records do not by themselves identify every physical manufacturing site, component supplier, distributor, pharmacy relationship, or commercial role outside the United States.
Clinical-development map
Section titled “Clinical-development map”Zepbound’s evidence base sits within the broader SURMOUNT program. Individual trials answer different questions and should not be merged into a single undifferentiated efficacy claim.
| Trial or program record | Population or research role | Product relationship |
|---|---|---|
| SURMOUNT-1 | Adults with obesity or overweight and related conditions, without type 2 diabetes | Pivotal weight-reduction evidence connected to the original product record |
| SURMOUNT-2 | Adults with obesity or overweight and type 2 diabetes | Weight-management evidence in a distinct diabetes population |
| SURMOUNT-3 | Tirzepatide following an intensive lifestyle intervention | Different run-in and study design from SURMOUNT-1 |
| SURMOUNT-4 | Randomized-withdrawal and continued-treatment design | Informs maintenance and withdrawal interpretation |
| SURMOUNT-OSA | Adults with moderate-to-severe obstructive sleep apnea and obesity | Supported the later OSA indication |
| SURMOUNT-5 | Head-to-head tirzepatide and semaglutide study | Comparative evidence that must retain its open-label design, population, endpoint, and duration |
| SURMOUNT-MMO | Ongoing morbidity and mortality outcomes study | Investigational outcomes context beyond current approved indications |
The SURMOUNT clinical-program record, SURMOUNT-1 registry record, SURMOUNT-5 registry record, SURMOUNT-MMO registry record, current label, and FDA OSA review provide trial-level entry points. Specific outcome comparisons should preserve population, comparator, duration, endpoint definition, missing-data approach, and analysis context.
US regulatory history
Section titled “US regulatory history”| Date | Event | Scope |
|---|---|---|
| May 13, 2022 | FDA approved Mounjaro | First US approval of a tirzepatide product; not a Zepbound obesity approval |
| November 8, 2023 | FDA approved Zepbound | Established the Zepbound product for long-term weight reduction and maintenance in a defined adult population |
| 2024–2025 | Supplemental records added single-dose vial strengths and related presentations | Expanded presentation and channel options without creating a new ingredient |
| December 20, 2024 | FDA approved the moderate-to-severe obstructive-sleep-apnea indication | Added a separate indication for adults with obesity |
| January 2026 | FDA approved the Zepbound KwikPen presentation | Added a four-dose, single-patient-use delivery presentation |
| April 2026 | Current label revision incorporated updated presentation and safety information | Current label date is not a new indication by itself |
The FDA original approval notice, FDA OSA approval notice, current DailyMed label, and Drugs@FDA application record provide the durable regulatory trail.
Commercial channels and availability
Section titled “Commercial channels and availability”Zepbound presentations have been introduced through more than one US commercial channel. Lilly began offering selected single-dose vials through its LillyDirect self-pay channel in August 2024 and later expanded the vial-strength range. These are dated commercial-distribution records, not permanent price, coverage, or inventory guarantees.
The August 2024 LillyDirect vial announcement documents the initial channel relationship. Current price, eligibility, dispensing pharmacy, insurance coverage, reimbursement, and available presentations should be checked separately and as of a specific date.
FDA approval and a listed presentation do not establish local stock. National, regional, pharmacy-level, and presentation-specific availability can differ.
Safety and comparison boundaries
Section titled “Safety and comparison boundaries”The current Zepbound label contains a boxed warning concerning thyroid C-cell tumors observed in rats and lists contraindications, warnings, precautions, adverse reactions, drug interactions, and population-specific information. The label should be consulted directly rather than replaced by a short summary.
Several interpretation limits are especially important:
- Zepbound’s label should not be transferred to Mounjaro merely because both contain tirzepatide.
- Shared incretin activity does not make Zepbound, Wegovy, Mounjaro, Foundayo, or other products interchangeable.
- A trial result does not establish superiority outside the studied population, comparator, duration, endpoint, dose, or analysis.
- The OSA indication does not imply approval for every sleep disorder, OSA severity, age group, or person without obesity.
- Presentation availability does not establish insurance coverage, affordability, stable supply, or local inventory.
- Product information is not a recommendation about individual treatment, dosing, switching, or suitability.
Related records
Section titled “Related records”- Tirzepatide for the active-ingredient record
- Eli Lilly for company, pipeline, manufacturing, and commercial-channel context
- GIP/GLP-1 receptor agonists for the mechanism and class record
- SURMOUNT for the clinical-development program
- Regulatory milestones for dated approval and label events
- Active ingredient vs brand vs product for product-identity distinctions
- Dose, formulation, and route for presentation interpretation
- Market access, coverage, and availability for access-status distinctions