Current FDA Status
- China approval completed: Mazdutide (marketed as Xinermei®) received NMPA approval in China for obesity (June 2025) and type 2 diabetes (September 2025)—marking it as the world's first dual GLP-1/glucagon receptor agonist approved for weight loss
- US development status: Currently in Phase 2 clinical trials (NCT06143956) for obesity in US populations
- FDA filing timeline: Phase 3 trials expected 2026-2027; NDA submission estimated 2027-2028
- FDA decision timeline: 2028-2029 (assuming successful Phase 3 results)
First dual GLP-1/glucagon approved
Ongoing in US population
Pivotal trials expected
Application filing to FDA
Estimated decision date
Phase 3 Trial Results (China)
While US Phase 2 trials are ongoing, China's Phase 3 GLORY-1 trial provides strong proof-of-concept data:
- In the GLORY-1 trial (adults with overweight/obesity), participants on the 6mg dose achieved 14.8% average weight loss at 48 weeks versus 0.5% with placebo.[1]
- The 4mg dose achieved 12.0% weight loss at 48 weeks, demonstrating dose-dependent efficacy.[1]
- Exceptional tolerability: Only 0.5% of participants discontinued due to adverse events on the 6mg dose, significantly lower than discontinuation rates seen with other GLP-1 medications (4-7%).[1]
- In the DREAMS-3 diabetes trial, mazdutide demonstrated superior glycemic control compared to semaglutide, with HbA1c reductions averaging 2.1% from baseline.[2]
Regulatory Significance
China's NMPA approval validates mazdutide's efficacy and safety profile. However, the FDA typically requires trials in populations that reflect US demographics, which is why Eli Lilly is conducting separate Phase 2 studies in the United States. These US trials will inform the Phase 3 program design and support FDA filing.
Development Timeline
Mazdutide's development pathway reflects a parallel track strategy: Innovent Biologics (China rights) pursued approval in China first, while Eli Lilly (US/global rights) follows a separate timeline for FDA approval.
| Phase | Status | Timeframe | Description |
|---|---|---|---|
| Phase 1 (Safety & Dosing) | ✓ Complete | ~2019–2021 | Early safety studies established tolerability profile |
| Phase 2 (China - Obesity) | ✓ Complete | 2021–2023 | Dose-ranging studies in Chinese population |
| Phase 2 (China - Diabetes) | ✓ Complete | 2022–2024 | Glycemic control demonstrated vs dulaglutide |
| Phase 3 (China - GLORY-1) | ✓ Complete | 2022–2024 | Pivotal obesity trial: 14.8% weight loss at 48 weeks |
| Phase 3 (China - DREAMS-3) | ✓ Complete | 2022–2024 | Diabetes trial: superior HbA1c reduction vs semaglutide |
| China NMPA Approval (Obesity) | ✓ Approved | June 2025 | First dual GLP-1/glucagon approved for weight loss |
| China NMPA Approval (Diabetes) | ✓ Approved | September 2025 | Approved for glycemic control in type 2 diabetes |
| Phase 2 (US - Obesity) | ⟳ Ongoing | 2024–2025 | US population trials (NCT06143956) |
| Phase 3 (US) | ⊙ Planned | 2026–2027 | Pivotal US trials expected to begin |
| NDA Submission (US) | ⊕ Projected | 2027–2028 | Formal filing for FDA approval |
| FDA Review & Decision | ⊕ Projected | 2028–2029 | FDA approval decision expected |
Summary for Readers: Mazdutide has completed all required clinical development in China and is already approved. For US approval, Eli Lilly is starting from Phase 2 to ensure the drug works similarly in diverse US populations before advancing to Phase 3 and FDA filing.
Approval Milestones
| Milestone | Date | Status | Details |
|---|---|---|---|
| Eli Lilly-Innovent Partnership | 2019 | ✓ Complete | Innovent acquires China rights; Lilly retains US/global |
| Phase 2 Results Published | December 2023 | ✓ Complete | Nature Communications publishes Phase 2 obesity data |
| GLORY-1 Results Published | January 2025 | ✓ Complete | New England Journal of Medicine Phase 3 obesity results |
| NMPA NDA Acceptance (Obesity) | February 2024 | ✓ Complete | China regulatory filing accepted for review |
| NMPA Approval (Obesity) | June 27, 2025 | ✓ Complete | World's first dual GLP-1/glucagon approved |
| NMPA Approval (Diabetes) | September 2025 | ✓ Complete | Second indication approved in China |
| US Phase 2 Initiation | 2024 | ✓ Complete | NCT06143956 trial recruiting US participants |
| US Phase 2 Completion | 2025-2026 | ⟳ Ongoing | Expected readout informing Phase 3 design |
| US Phase 3 Initiation | 2026-2027 | ⊙ Planned | Pivotal trials in US population |
| NDA Submission (US) | 2027-2028 | ⊕ Projected | Filing to FDA for obesity and/or diabetes |
| FDA Acceptance for Review | ≈ 60 days post-submission | ◯ Future | Agency confirms application completeness |
| PDUFA Date Set | Upon acceptance | ◯ Future | Target decision deadline assigned |
| FDA Decision | 2028-2029 | ⊕ Projected | Assuming standard review timeline |
| Commercial Launch (US) | 2029 | ⊕ Projected | If approved |
Summary for Readers: China approval provides strong validation, but US approval requires separate clinical trials. After Phase 2 completion and Phase 3 initiation, the timeline follows standard FDA review: submission, acceptance, review (6-12 months), and final decision.
Approval Predictions
Best-Case Scenario
Timeline: Late 2027 / early 2028 approval
What would need to happen:
- Phase 2 data strongly supports Phase 3 advancement (2025)
- Accelerated Phase 3 initiation (early 2026)
- FDA grants priority review designation
- NDA submission by mid-2027
- 6-month priority review granted
Most Likely Scenario
Timeline: 2028-2029 approval
Assumptions:
- Phase 2 completion mid-2025 to early 2026
- Phase 3 trials 2026-2027
- NDA submission 2027-2028
- Standard 10-12 month FDA review
- No major FDA questions or delays
Delayed Scenario
Timeline: 2029-2030 or later
Potential causes:
- Phase 2 requires additional studies or dose optimization
- FDA requests cardiovascular outcomes trial (CVOT)
- Manufacturing or quality issues arise
- Complete Response Letter requiring resubmission
Historical Comparison: Similar Drug Approvals
| Drug | Developer | Indication | NDA to Approval | Notes |
|---|---|---|---|---|
| Semaglutide (Wegovy) | Novo Nordisk | Obesity | ~7 months (priority) | Priority review granted; approved 2021 |
| Tirzepatide (Zepbound) | Eli Lilly | Obesity | ~6 months (priority) | First dual GLP-1/GIP; priority review; approved 2023 |
| Liraglutide (Saxenda) | Novo Nordisk | Obesity | ~10 months (standard) | Standard review; approved 2014 |
Historical context: Dual agonist obesity medications (like tirzepatide) have received priority review. As the first dual GLP-1/glucagon agonist, mazdutide may qualify for expedited review if Phase 3 results are compelling and demonstrate advantages over existing therapies.
Summary for Readers: Most new obesity drugs take 10-12 months from NDA submission to FDA approval with standard review. Priority review (granted for novel, highly effective therapies) can shorten this to 6-7 months. Mazdutide's unique dual mechanism may support priority review eligibility.
FDA Approval Process
Once Eli Lilly completes Phase 3 trials and submits its New Drug Application (NDA), mazdutide will move through a structured FDA review process. Here's what that journey looks like:
Complete US Phase 2 & 3 Trials
Eli Lilly must complete ongoing Phase 2 trials in US populations, analyze results, design and execute Phase 3 pivotal trials demonstrating safety and efficacy comparable to China's GLORY-1 results.
NDA Submission
Eli Lilly submits a complete application package containing all clinical trial data, manufacturing details, proposed labeling, and safety plans for obesity and/or type 2 diabetes indications.
FDA Filing Decision
FDA reviews the application for completeness. If accepted, they assign a PDUFA date (the target decision deadline) and determine if it qualifies for Priority Review (6 months) or Standard Review (10-12 months).
FDA Review Period
FDA scientists evaluate safety, efficacy, manufacturing quality, and labeling. They may request additional data or schedule an advisory committee meeting if needed.
PDUFA Date Decision
By the PDUFA date, the FDA must issue one of three decisions:
- Approval: Drug can be marketed
- Complete Response Letter: Issues need to be addressed before approval
- Extend review: More time needed (rare)
Summary for Readers: The FDA approval process typically takes 6-12 months after NDA submission. The journey moves through five key stages: trial completion, submission, filing acceptance, detailed review, and final decision. Special designations can significantly accelerate this timeline.
Post-Approval Rollout
If Approved:
- 1-3 months - Commercial launch begins: Product stocked in pharmacies/distributors; US brand name announced (Xinermei® is China-only brand)
- 3-6 months - Insurers evaluate the therapy: Formulary inclusion decisions; patient access expands
- 6-12 months - Broader insurance coverage: Most commercial plans add to formulary; patient-assistance programs introduced
- Competitive positioning: As first dual GLP-1/glucagon, mazdutide will compete with Wegovy, Zepbound, and orforglipron (if approved)
If Delayed or Not Approved:
- The FDA could issue a Complete Response Letter (CRL) requesting more data or highlighting manufacturing/safety issues
- Additional long-term safety or cardiovascular outcome studies might be required (increasingly common for obesity drugs)
- The company may resubmit, adding months to years of delay
- Eli Lilly's strong regulatory track record (tirzepatide, semaglutide approvals) reduces likelihood of major delays
Summary for Readers: After FDA approval, most drugs reach pharmacies within a few months. Insurance coverage often follows within half a year as payers complete formulary reviews. Eli Lilly's existing GLP-1 infrastructure (from Mounjaro/Zepbound) will facilitate rapid rollout.
FAQs
Based on current development timelines, FDA approval is most likely in 2028-2029. Eli Lilly is currently conducting Phase 2 trials in the US (expected completion 2025-2026), followed by Phase 3 trials (2026-2027), NDA submission (2027-2028), and FDA review (6-12 months). However, if mazdutide receives priority review as the first dual GLP-1/glucagon agonist, approval could come as early as late 2027.
Not yet through prescription. Mazdutide is not FDA-approved in the US. However, you may be able to access it through:
- Clinical trials: Eli Lilly is recruiting for Phase 2 trials (NCT06143956). Search ClinicalTrials.gov for "mazdutide" or "LY3305677" to find enrolling trials near you.
- International access: Mazdutide is approved in China as Xinermei®, but obtaining it for personal use in the US involves complex importation regulations and is not recommended without medical supervision.
The PDUFA date (Prescription Drug User Fee Act date) is the FDA's target deadline for completing its review of the NDA. It's typically set approximately 60 days after the FDA accepts the NDA for filing. For mazdutide, we'll likely know the PDUFA date in 2028 (assuming a 2027-2028 NDA submission). This date gives patients, clinicians, and investors a concrete timeline for when to expect a decision.
Insurance coverage will depend on several factors: FDA-approved indications (obesity vs diabetes), payer formulary decisions, and prior authorization requirements. Based on current GLP-1 coverage patterns, we expect:
- Type 2 Diabetes: Broader coverage, as diabetes is widely covered by most insurers
- Obesity: More variable coverage; some insurers exclude obesity medications entirely, while others cover them with strict criteria (e.g., BMI ≥30 or ≥27 with comorbidity)
Eli Lilly will likely negotiate with payers for favorable formulary placement, and patient assistance programs may be available for those without coverage. More information will be available closer to launch.
Recent GLP-1 and dual agonist approvals have varied based on priority review status:
- Semaglutide (Wegovy): ~7 months (priority review, obesity indication, 2021)
- Tirzepatide (Zepbound): ~6 months (priority review, obesity indication, 2023)
- Liraglutide (Saxenda): ~10 months (standard review, obesity indication, 2014)
If mazdutide receives priority review (which is likely given the novel dual GLP-1/glucagon mechanism), it could follow a similar 6-7 month timeline. If not, expect the standard 10-12 months.
Common reasons for approval delays include:
- Additional safety data requests: The FDA may want longer-term follow-up or cardiovascular outcomes data (CVOT)
- Phase 2/3 results differ from China data: If US trial results don't replicate GLORY-1's 14.8% weight loss, this could delay filing
- Manufacturing issues: Problems identified during FDA facility inspections
- Complete Response Letter (CRL): FDA's formal notification that the application is not ready for approval, requiring resubmission
- Advisory committee meeting: The FDA may convene an external expert panel to review the data, which can add 3-6 months to the timeline
Eli Lilly's strong track record with GLP-1 drugs (tirzepatide/Zepbound, semaglutide license) and mazdutide's China approval reduce the likelihood of major delays, but they remain possible.
Likely yes, but the timeline may differ. In China, mazdutide received approval for obesity first (June 2025), followed by diabetes (September 2025). Eli Lilly may pursue a similar strategy in the US—filing for one indication first, then adding the second later. Each indication requires separate FDA review and approval. If both are approved, mazdutide would be marketed with different labeling and potentially different dosing for each indication, similar to how semaglutide is marketed as Ozempic (diabetes) and Wegovy (obesity).
This is a result of the development partnership structure:
- Innovent Biologics (which holds China rights) prioritized development in the Chinese market and completed Phase 2 and Phase 3 trials there first
- Eli Lilly (which holds US/global rights) is following a separate development pathway with trials in US populations
The FDA typically requires trials conducted in diverse patient populations that reflect US demographics, ethnic backgrounds, and dietary patterns, which is why Lilly is conducting separate Phase 2 trials in the United States rather than simply submitting China's GLORY-1 data. This parallel development is common when different companies hold regional rights—each pursues regulatory approval independently in their respective markets.
Sources & References
- Ji L, Jiang H, Bi Y, et al. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025;392(4):301-312. doi:10.1056/NEJMoa2411528. PMID: 40421736.
- Innovent Biologics. Innovent's GLP-1RA bests semaglutide's glycaemic control in Phase III. Clinical Trials Arena. 2024. https://www.clinicaltrialsarena.com/news/innovent-biologics-mazdutide-glp-1ra-phase-iii-dreams-3/
- Innovent Biologics. Innovent Announces Mazdutide, First Dual GCG/GLP-1 Receptor Agonist, Received Approval from China's NMPA for Chronic Weight Management. PR Newswire. June 27, 2025. https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html
- Innovent Biologics. Innovent Announces Mazdutide Received Approval from China's NMPA for Glycemic Control in Adults with Type 2 Diabetes. PR Newswire. September 2025. https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-received-approval-from-chinas-nmpa-for-glycemic-control-in-adults-with-type-2-diabetes-302561434.html
- Eli Lilly and Company. A Master Protocol Study of LY3305677 (Mazdutide) in Participants With Overweight or Obesity. ClinicalTrials.gov Identifier: NCT06143956. Updated November 30, 2023. https://clinicaltrials.gov/study/NCT06143956
- Ji L, Gao L, Jiang H, et al. Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial. EClinicalMedicine. 2022;54:101727. doi:10.1016/j.eclinm.2022.101727. PMID: 36247927.
- Ji L, Jiang H, Cheng Z, et al. A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Nat Commun. 2023;14(1):8042. doi:10.1038/s41467-023-44067-4. PMID: 38092790.
- U.S. Food and Drug Administration. "Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review." https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
Last updated October 6, 2026
Disclaimer
The information on this page is for educational and informational purposes only and is not intended as medical advice. Honest Care does not provide medical diagnosis, treatment, or individualized recommendations. Always seek the advice of your physician or other qualified healthcare professional regarding any medical condition or treatment.
While this content has been reviewed for accuracy and balance, new evidence may emerge after publication. Drug availability, indications, and insurance coverage can change over time. Honest Care makes no warranties as to completeness or currentness of the information and is not responsible for decisions made based on this content.