Current FDA Status
Investigational Drug — Not Yet FDA-Approved
CT-388 is currently in Phase 2 clinical trials. Phase 3 is planned to start in H1 2026. FDA approval is estimated for 2029-2030 if trials succeed. The drug is not available by prescription.
| Milestone | Status | Timeline |
|---|---|---|
| Phase 1/1b | ✅ Complete | 2022-2024 |
| Phase 2 (Obesity) | 🔄 Enrolling | 2024-2026 |
| Phase 2 (T2D) | 🔄 Enrolling | 2024-2026 |
| Phase 3 Start | 📅 Planned | H1 2026 |
| Phase 3 Complete | — | ~2028 |
| NDA Filing | — | ~2028-2029 |
| FDA Decision | — | 2029-2030 |
| Market Launch | — | 2030 |
Detailed Development Timeline
Completed Milestones
- December 2023: Roche announces $2.7B acquisition of Carmot Therapeutics[1]
- January 2024: Acquisition completed
- May 2024: Phase 1b results announced (18.8% weight loss at 24 weeks)[2]
- June 2025: T2D cohort results published at ADA (3.0% HbA1c reduction)[3]
- August 2024: Phase 2 trials initiated
- September 2025: Phase 3 decision announced at Roche Pharma Day[4]
Upcoming Milestones
- Q1 2026: Phase 2 top-line results expected
- H1 2026: Phase 3 program initiation
- 2026-2028: Phase 3 pivotal trials (likely 52-72 weeks)
- 2028-2029: NDA filing anticipated
- 2029-2030: FDA review and potential approval
- 2030: Roche's target market entry year
Approval Timeline Scenarios
| Scenario | Approval | Key Assumptions |
|---|---|---|
| 🚀 Optimistic | Late 2029 | Phase 3 success, Priority Review, no CRL |
| 📊 Baseline | Mid 2030 | Standard timelines, Phase 3 success |
| ⚠️ Delayed | 2031+ | Phase 3 setback, FDA requests additional data |
Roche's guidance: The company is targeting 2030 market entry and will "refine the guidance on timelines" when Phase 3 kicks off in H1 2026.[4]
Pipeline Comparison
CT-388 enters a competitive pipeline landscape. Here's how development timelines compare:
| Drug | Company | Phase | Est. Approval |
|---|---|---|---|
| CagriSema | Novo Nordisk | Phase 3 | 2025-2026 |
| Retatrutide | Eli Lilly | Phase 3 | 2026-2027 |
| Orforglipron | Eli Lilly | Phase 3 | 2026-2027 |
| VK2735 | Viking | Phase 3 (H1 2026) | 2028-2029 |
| CT-388 | Roche | Phase 2 | 2029-2030 |
Market entry position: CT-388 will be a later entrant, but Roche's commercial infrastructure and potential combination therapies (CT-388 + Petrelintide) could provide differentiation.
Regulatory Pathway
Expected Approval Pathway
- Initial indication: Likely chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity
- Additional indications: Type 2 diabetes (separate Phase 2/3 program ongoing)
- Review type: Standard Review (10 months) or Priority Review (6 months) if criteria met
- Advisory committee: Possible but not guaranteed
Potential for Expedited Pathways
- Breakthrough Therapy: Possible if CT-388 demonstrates substantial improvement over existing treatments
- Fast Track: Obesity qualifies as serious condition; possible if unmet need demonstrated
- Priority Review: Could be requested if significant advancement shown
FAQs
Potentially, if Roche seeks and receives Breakthrough Therapy designation or Priority Review. However, several factors suggest the 2029-2030 timeline is realistic:
- Phase 3 hasn't started yet (H1 2026 planned)
- Pivotal trials typically run 52-72 weeks
- FDA review takes 6-10 months
Roche's target of 2030 market entry appears realistic barring unexpected delays.
Likely yes, eventually. Roche is running parallel Phase 2 development in T2D (NCT06628362). The T2D cohort showed remarkable results: 3.0% HbA1c reduction at 12 weeks with 100% achieving HbA1c ≤6.5%.
T2D approval could come simultaneously with or shortly after obesity approval, depending on trial timelines.
Potential delays could result from:
- Phase 3 issues: Unexpected safety signals, insufficient efficacy
- Manufacturing: Supply chain or quality issues
- FDA requests: Additional studies, Complete Response Letter (CRL)
- Safety concerns: Post-marketing signals from similar drugs
However, Roche's extensive regulatory experience reduces some of these risks.
Sources & References
- Roche. "Roche enters into a definitive merger agreement to acquire Carmot Therapeutics." December 2023. https://www.roche.com/media/releases/med-cor-2023-12-04
- Roche. "Roche reports positive Phase Ib results for CT-388." May 2024. https://www.roche.com/media/releases/med-cor-2024-05-16
- Steinberg A, et al. "Glycemic Control, Weight Reduction, and Safety with CT-388." Diabetes 2025;74(Supplement_1):763-P. https://diabetesjournals.org/diabetes/article/74/Supplement_1/763-P/160045/
- FierceBiotech. "Roche unveils strategy to become 'top 3' obesity company." September 2025. https://www.fiercebiotech.com/biotech/we-have-will-roche-unveils-strategy-become-top-3-obesity-company
Last updated October 6, 2026
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