Drugs / ARD-101
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT05153434 | May 2022 → Sep 2024 | Prader-Willi syndrome | Aardvark Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05215847 | Mar 2022 → Feb 2023 | obesity disorder | Aardvark Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05121441 | Nov 2021 → Nov 2022 | obesity disorder | Aardvark Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06828861 | Dec 2024 → May 2026 | Prader-Willi syndrome | Aardvark Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT07197034 | Jul 2024 → Apr 2026 | Prader-Willi syndrome, obesity, hyperphagia, and developmental delay | Aardvark Therapeutics, Inc. | Terminated | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT02759926 Comparator | Aug 2011 → Nov 2015 | obesity disorder | Universitaire Ziekenhuizen KU Leuven | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-08-05 | Aardvark Therapeutics, Inc. | Regulatory Aardvark Therapeutics Announces Receipt of FDA Rare Pediatric Disease Designation for Prader-Willi Syndrome and Expands the Ongoing Phase 2 Clinical Trial aardvarktherapeutics.com ↗
The FDA granted Aardvark Therapeutics a Rare Pediatric Designation for the use of ARD-101 in Prader-Willi Syndrome (PWS), a rare genetic disease characterized by extreme and unabating hunger. |
| 2023-06-20 | Aardvark Therapeutics, Inc. | Regulatory Aardvark Therapeutics Announces FDA Orphan Drug Designation Granted to ARD-101, a Novel Drug Candidate for Prader-Willi Syndrome aardvarktherapeutics.com ↗
The FDA granted Aardvark Therapeutics a Rare Pediatric Designation for the use of ARD-101 in Prader-Willi Syndrome (PWS), a rare genetic disease characterized by extreme and unabating hunger. |
All press releases naming this drug 6 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARD-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05215847 ↗ |
| Known as | Denatonium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02759926 ↗ |
| Action | Activate | “ARD-101, a gut-restricted TAS2R agonist, reduces hunger in adults and promotes weight loss in DIO mice with DPP-4 inhibition.” PMID 41833222 ↗ Mar 2026 |
| Modality | Small molecule | “ARD-101, a small molecule targeting bitter taste receptors (TAS2Rs), in obese subjects with a body mass index (BMI) of 30-45 kg/m2.” NCT05121441 ↗ |
| Route | Oral | “Twice daily, oral administration” NCT05121441 ↗ |