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 Timeline and 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:
- April 21, 2026
- Indication:
- For the treatment of obesity.
Announcement
BioAge Labs, Inc. today reported results from the Phase 1 clinical trial of BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor.
AI Summary
BioAge Labs today reported Phase 1 results for BGE-102, a potent, structurally novel, orally available, brain‑penetrant small molecule NLRP3 inhibitor. Both the 120 mg and newly announced 60 mg once‑daily doses produced ≥85% median reductions in hsCRP in participants with obesity and elevated baseline inflammation, with rapid, profound, and sustained effects.
BGE-102 also lowered IL‑6 (60 mg: 78% at Day 7, 70% at Day 14, 55% at Day 21; 120 mg: 69% at Day 7, 58% at Day 14) and reduced fibrinogen (60 mg: 20% Day 7, 19% Day 14, 23% Day 21; 120 mg: 24% Day 7, 30% Day 14), supporting upstream NLRP3 inhibition. The drug was well tolerated across doses; adverse events were mild to moderate and self‑limited, with no serious adverse events, no discontinuations, and no meaningful changes in vital signs, ECGs, or labs.
BioAge plans a Phase 2 cardiovascular proof‑of‑concept trial to start mid‑2026 with results expected by year‑end, and a Phase 1b/2a study in diabetic macular edema planned mid‑2026 with results anticipated mid‑2027. Management will host a conference call and webcast today at 8:00 AM ET to review the data.
Read Announcement- Drug:
- BGE-102
- Announced Date:
- January 20, 2026
- Indication:
- For the treatment of obesity.
Announcement
BioAge Labs, Inc. announced expansion of its BGE-102 development program into ophthalmology, with an initial proof-of-concept (POC) study in patients with diabetic macular edema (DME). BGE-102 is a potent, structurally novel, orally administered small molecule NLRP3 inhibitor with potential for therapeutic retinal exposure.
AI Summary
BioAge Labs announced it is expanding BGE-102 into ophthalmology with a proof-of-concept study in patients with diabetic macular edema (DME). BGE-102 is a potent, structurally novel, orally administered small-molecule NLRP3 inhibitor designed to reach the retina. Because NLRP3 drives inflammatory damage in retinal diseases, an oral drug that hits this target could lessen the need for frequent intravitreal injections and reduce treatment burden for patients.
Preclinical data showed dose-dependent preservation of retinal vascular integrity, near-complete protection from leakage, and up to 90% preservation of microvasculature; NLRP3 inhibition also cut lipofuscin accumulation by about 80%. In an ongoing Phase 1 trial, BGE-102 has been well tolerated and produced strong reductions in inflammatory biomarkers (hsCRP, IL-6, IL-1β). BioAge plans a randomized Phase 1b/2a DME trial starting mid-2026, testing monotherapy and combination with a VEGF inhibitor. The primary endpoint is percent change in intraocular IL-6, with results expected mid-2027 and potential expansion to other NLRP3-driven retinal diseases.
Read Announcement- Drug:
- BGE-102
- Announced Date:
- January 12, 2026
- Indication:
- For the treatment of obesity.
Announcement
BioAge Labs, Inc. announced additional positive interim data from the ongoing Phase 1 clinical trial evaluating BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for the treatment of patients with cardiovascular risk factors.
AI Summary
BioAge Labs reported positive interim Phase 1 results for BGE-102, an oral, brain-penetrant NLRP3 inhibitor, from a multiple ascending dose cohort in obese participants with elevated inflammation (hsCRP >3 mg/L). At 120 mg once daily, BGE-102 produced a median 86% reduction in hsCRP by Day 14, with 93% of treated participants (13 of 14) reaching hsCRP levels below 2 mg/L. Effects were rapid, with most participants hitting reduced-risk levels by Day 7.
BGE-102 also lowered other key inflammatory markers: a 44% median reduction in serum IL-6 and a 30% reduction in fibrinogen at Day 14. Ex vivo assays showed 93% suppression of IL-1β at trough, consistent with strong target engagement. CSF IL-6 fell in two participants with elevated baseline levels, supporting brain penetration.
The drug was well tolerated with mostly mild to moderate, self-limited adverse events. BioAge said a patent was issued covering new composition and binding site, and full Phase 1 data plus initiation of a Phase 2a study are planned for the first half of 2026.
Read Announcement- Drug:
- BGE-102
- Announced Date:
- December 4, 2025
- Indication:
- For the treatment of obesity.
Announcement
BioAge Labs, Inc. announced positive interim data from the ongoing Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) clinical trial evaluating BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for treatment of patients with cardiovascular risk factors.
AI Summary
BioAge Labs reported positive interim Phase 1 SAD/MAD results for BGE-102, an oral, brain‑penetrant NLRP3 inhibitor being developed for patients with cardiovascular risk factors. BGE-102 was well tolerated across evaluated doses (10–120 mg) in single and initial multiple dose cohorts, with adverse events mostly mild to moderate and resolving without intervention. Pharmacokinetics showed dose proportionality and supported once‑daily dosing; in MAD cohorts, 60 mg and higher maintained plasma levels above the IC90 for 24 hours. Pharmacodynamically, the drug produced 90–98% suppression of IL‑1β at Day 14 in an ex vivo whole blood assay.
Importantly, cerebrospinal fluid concentrations at 60 mg and above exceeded IC90 at Day 14, indicating high brain penetration and the potential to address both central and peripheral inflammation. BioAge is expanding MAD cohorts to include obese participants with elevated hsCRP to seek early biomarker proof‑of‑concept, with data expected in the first half of 2026 and plans to inform a Phase 2a study.
Read Announcement- Drug:
- BGE-102
- Announced Date:
- September 15, 2025
- Indication:
- For the treatment of obesity.
Announcement
Shanghai Stock Exchange listed company HitGen Inc congratulates its partner BioAge Labs, Inc on the initiation of a Phase 1 clinical study of BGE-102, a novel, potent NLRP3 inhibitor developed from a hit compound identified using HitGen's industry-leading DEL technology platform.
AI Summary
Shanghai Stock Exchange–listed HitGen Inc. congratulated its partner BioAge Labs on the start of a Phase 1 clinical study of BGE-102. This potent, orally available, brain-penetrant NLRP3 inhibitor was discovered using HitGen’s leading DNA-encoded library (DEL) platform. The study launch triggered an undisclosed milestone payment to HitGen.
BGE-102 is a novel small molecule designed to block NLRP3, a key driver of age-related inflammation linked to obesity, heart disease, and neurodegenerative conditions. BioAge is initially developing it for the treatment of obesity. HitGen’s DEL screening helped identify the hit compound, which was then optimized into BGE-102 through joint research efforts.
HitGen’s DEL technology features over 1.2 trillion small molecules and accelerates early drug discovery. The partnership with BioAge highlights the platform’s power to uncover structurally distinct, high-potency candidates against challenging targets. Both companies plan to continue collaborating on additional drug leads using HitGen’s DEL capabilities.
Read Announcement- Drug:
- BGE-102
- Announced Date:
- August 15, 2025
- Indication:
- For the treatment of obesity.
Announcement
BioAge Labs, Inc. announced that the first participant has been dosed in a Phase 1 clinical trial evaluating BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration being developed initially for the treatment of obesity.
AI Summary
BioAge Labs announced the first participant has been dosed in a Phase 1 clinical trial of BGE-102, a new, oral small-molecule NLRP3 inhibitor designed to treat obesity. This study will test safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers.
BGE-102 blocks the NLRP3 inflammasome, a key driver of inflammation linked to obesity and age-related diseases. The compound shows high potency, supports once-daily dosing and has strong brain penetration to target both neuroinflammation and systemic inflammation.
In preclinical obesity models, BGE-102 alone led to up to 15% weight loss, similar to semaglutide, and achieved about 25% loss when combined with it. GLP toxicology studies revealed no significant safety concerns.
The randomized, double-blind, placebo-controlled trial includes single and multiple ascending dose parts administered once daily for 14 days. BioAge expects initial single-dose data by year-end 2025 and plans a proof-of-concept obesity study in 2026 with top-line results by year-end.
Read Announcement- 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
