This section highlights FDA-related milestones and regulatory updates for drugs developed by Strategy (MSTR).
Over the past two years, Strategy has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MET-097i and MET-233i. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
MET-097i FDA Regulatory Events
MET-097i is a drug developed by Strategy for the following indication: GLP-1 RA Candidate.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MET-097i
- Announced Date:
- September 29, 2025
- Indication:
- GLP-1 RA Candidate
Announcement
Metsera, Inc announced positive topline data from VESPER-1 and positive data from a planned interim analysis for tolerability of VESPER-3 – two Phase 2b trials of MET-097i, a first-in-class fully biased, ultra-long acting GLP-1 receptor agonist (RA) with potential for monthly dosing.
AI Summary
In the Phase 2b VESPER-1 trial, weekly subcutaneous doses of MET-097i at 0.4 to 1.2 mg produced placebo-subtracted mean weight loss up to 14.1% after 28 weeks. Exploratory data at 36 weeks showed continued gains with no plateau. The study included 239 adults with overweight or obesity, achieved high retention (97.1%), and only 2.9% discontinued due to AEs.
In the planned interim analysis of VESPER-3, monthly dosing regimens with two titration steps yielded a diarrhea rate similar to placebo, a 13% risk difference for nausea, and an 11% risk difference for vomiting at 12 weeks. These tolerability metrics suggest MET-097i may offer a GI side effect profile comparable to current therapies.
MET-097i is an ultra-long acting GLP-1 RA engineered for monthly dosing. Metsera plans global Phase 3 trials in late 2025. MET-097i could offer competitive weight loss with greater convenience and fewer GI side effects.
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MET-233i FDA Regulatory Events
MET-233i is a drug developed by Strategy for the following indication: Amylin Candidate.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MET-233i
- Announced Date:
- June 9, 2025
- Indication:
- Amylin Candidate
Announcement
Metsera, Inc. announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long acting amylin analog engineered for class-leading durability, potency, and combinability with Metsera's fully-biased monthly GLP-1 receptor agonist candidate, MET-097i.
AI Summary
Metsera, Inc. announced positive topline results from its Phase 1 clinical trial of MET-233i, an ultra–long acting amylin analog engineered for superior durability, potency, and the ability to be combined with its monthly GLP-1 receptor agonist candidate, MET-097i. In the study, MET-233i produced up to an 8.4% placebo-subtracted weight loss by Day 36 and showed a 19‐day half-life, supporting the feasibility of once-monthly dosing both as a monotherapy and in combination with MET-097i.
The trial, which enrolled participants with overweight or obesity, also demonstrated dose-linear pharmacokinetics and a favorable safety profile with mostly mild side effects. These findings suggest that MET-233i could provide effective and convenient weight management and may pave the way for the first monthly GLP-1 and amylin combination therapy. Metsera plans to advance the clinical development of this innovative approach further.
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