Aardvark Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Aardvark Therapeutics (AARD).
Over the past two years, Aardvark Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ARD-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ARD-201 FDA Regulatory Events
ARD-201 is a drug developed by Aardvark Therapeutics for the following indication: For the treatment of metabolic obesity and obesity-related conditions.
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:
- ARD-201
- Announced Date:
- August 12, 2025
- Indication:
- For the treatment of metabolic obesity and obesity-related conditions.
Announcement
Aardvark Therapeutics, Inc. announced new positive preclinical data demonstrating the potential of ARD-201 for the treatment of metabolic obesity and obesity-related conditions.
AI Summary
Aardvark Therapeutics announced positive preclinical results for ARD-201 in diet-induced obesity mice. Oral ARD-201 led to about 19% body weight loss after 30 days and slowed weight regain after stopping tirzepatide. When paired with a low tirzepatide dose, the combination outperformed a high tirzepatide dose alone.
The study also found ARD-201 alone maintained weight loss as well as continued high-dose tirzepatide. Being oral and at a lower equivalent human dose, ARD-201 may offer better tolerability and convenience for patients.
Aardvark will start two Phase 2 trials based on these findings. The POWER trial, in late 2025, will test if ARD-201 can prevent weight rebound after stopping GLP-1 receptor agonists. The STRENGTH trial, planned for early 2026, will explore ARD-201’s weight loss effects alone and combined with GLP-1 therapy.
Read Announcement
Aardvark Therapeutics FDA Events - Frequently Asked Questions
As of now, Aardvark Therapeutics (AARD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Aardvark Therapeutics (AARD) has reported FDA regulatory activity for ARD-201.
The most recent FDA-related event for Aardvark Therapeutics occurred on August 12, 2025, involving ARD-201. The update was categorized as "Positive Data," with the company reporting: "Aardvark Therapeutics, Inc. announced new positive preclinical data demonstrating the potential of ARD-201 for the treatment of metabolic obesity and obesity-related conditions."
Currently, Aardvark Therapeutics has one therapy (ARD-201) targeting the following condition: For the treatment of metabolic obesity and obesity-related conditions..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:AARD) was last updated on 8/14/2025 by MarketBeat.com Staff
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