This section highlights FDA-related milestones and regulatory updates for drugs developed by BioAge Labs (BIOA).
Over the past two years, BioAge Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BGE-102 and tirzepatide. 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.
BGE-102 FDA Regulatory Events
BGE-102 is a drug developed by BioAge Labs for the following indication: For the treatment of 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:
- BGE-102
- Announced Date:
- June 21, 2025
- Indication:
- For the treatment of obesity.
Announcement
BioAge Labs, Inc. announced that it will present new preclinical data supporting apelin receptor (APJ) agonism for the treatment of diabetic obesity and heart failure with preserved ejection fraction (HFpEF).
AI Summary
BioAge Labs, Inc. announced it will present new preclinical data supporting apelin receptor (APJ) agonism as a potential treatment for diabetic obesity and heart failure with preserved ejection fraction (HFpEF). The research, set to be shared at the American Diabetes Association’s 85th Scientific Sessions, highlights how APJ activation improves glycemic control by reducing HbA1c levels and enhancing glucose tolerance in diabetic obesity models. It also shows that APJ agonists offer cardioprotective effects by decreasing cardiac hypertrophy and lowering markers of heart injury in HFpEF models. These benefits were further enhanced when used in combination with incretin therapy, suggesting that APJ agonism could serve as a promising pharmacological exercise mimetic. The findings support the continued development of next-generation APJ agonists, available in both oral and long-acting injectable formulations, for treating obesity and its cardiovascular complications.
Read Announcement- Drug:
- BGE-102
- Announced Date:
- May 29, 2025
- Indication:
- For the treatment of obesity.
Announcement
BioAge Labs, Inc. announced completion of IND-enabling studies for BGE-102 and updated clinical development milestones for the compound.
AI Summary
BioAge Labs, Inc. announced that it has finished IND-enabling studies for its new compound BGE-102, an orally available small-molecule NLRP3 inhibitor being developed for obesity. The company updated its clinical development milestones, planning to submit its IND application in mid-2025. If approved, BioAge intends to begin Phase 1 clinical trials using single and multiple ascending dose strategies, with initial SAD data expected by the end of 2025.
BGE-102 has shown promising results in preclinical obesity models, where it induced significant weight loss both when used alone and in combination with GLP-1 receptor agonists. The compound stands out due to its novel binding site, high potency, and potential for once-daily dosing, making it a strong candidate for a best-in-class treatment.
Read Announcement
Tirzepatide FDA Regulatory Events
Tirzepatide is a drug developed by BioAge Labs for the following indication: For 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:
- tirzepatide
- Announced Date:
- December 6, 2024
- Indication:
- For obesity
Announcement
BioAge Labs announced that the Company has made the decision to discontinue the ongoing STRIDES Phase 2 study of its investigational drug candidate azelaprag as monotherapy and in combination with tirzepatide after liver transaminitis without clinically significant symptoms was observed in some subjects receiving azelaprag.
AI Summary
BioAge Labs announced that it is discontinuing its STRIDES Phase 2 study of the investigational drug candidate azelaprag, both as a monotherapy and when combined with tirzepatide. This decision follows observations of liver transaminitis in some subjects receiving azelaprag, even though these elevated levels did not lead to any clinically significant symptoms. Out of 204 enrolled subjects, 11 in the azelaprag treatment groups showed increased transaminase levels, while no such issues were noted in the tirzepatide-only group.
The company has halted dosing for all participants and will continue clinical follow-up off drug. BioAge Labs will evaluate the available trial data and plans to share updated strategies for azelaprag in Q1 2025. Patient safety remains a top priority as the company reviews these findings and continues to advance other therapies targeting metabolic aging.
Read Announcement
