This section highlights FDA-related milestones and regulatory updates for drugs developed by Kailera Therapeutics (KLRA).
Over the past two years, Kailera Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ribupatide and KAI-9531. 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.
Ribupatide FDA Regulatory Events
Ribupatide is a drug developed by Kailera Therapeutics for the following indication: GLP-1/GIP/glucagon receptor tri-agonist in obesity.
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:
- ribupatide
- Announced Date:
- October 1, 2026
- Indication:
- GLP-1/GIP/glucagon receptor tri-agonist in obesity.
Announcement
Kailera Therapeutics, Inc. announced Phase 1 data for ribupatide injection, a GLP-1/GIP receptor dual agonist currently advancing through global Phase 3 clinical trials, presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD).
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KAI-9531 FDA Regulatory Events
KAI-9531 is a drug developed by Kailera Therapeutics for the following indication: for the treatment of people living with obesity or overweight.
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:
- KAI-9531
- Announced Date:
- September 30, 2026
- Indication:
- for the treatment of people living with obesity or overweight.
Announcement
Kailera Therapeutics, Inc. announced the completion of enrollment in the KaiNETIC global Phase 3 clinical program. The KaiNETIC program, which encompasses three trials – KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 – is evaluating ribupatide injection (also known as KAI-9531), an investigational once-weekly dual GLP-1/GIP receptor agonist peptide, for the treatment of people living with obesity or overweight.
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