Drugs / AUT00063
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT02832128 | May 2016 → Apr 2017 | hearing loss disorder | Autifony Therapeutics Limited | Completed | No outcome recorded |
| Phase 2 | NCT02315508 | Oct 2014 → Dec 2015 | tinnitus | Autifony Therapeutics Limited | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02345031 Comparator | Jan 2015 → May 2016 | presbycusis | Autifony Therapeutics Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2016-08-09 | Autifony Therapeutics Limited | Results Autifony Announces Results from Completed CLARITY-1, Phase IIa Trial of AUT00063 in Age-related Hearing Loss autifony.com ↗
today released the results of its CLARITY-1 clinical trial of AUT00063 conducted in subjects with age-related hearing loss. |
| 2016-04-28 | Autifony Therapeutics Limited | Results Update from Autifony Therapeutics’ QUIET-1 tinnitus clinical trial autifony.com ↗
Headline data from QUIET-1 confirm lack of efficacy of AUT00063 in the treatment of people with mild-to-moderate tinnitus |
| 2015-10-13 | Autifony Therapeutics Limited | Results Update from Autifony Therapeutics’ QUIET-1 clinical trial autifony.com ↗
Following its review of the results from 58 subjects who have completed the QUIET-1 trial, the Independent Data Monitoring Committee recommended that Autifony terminate recruitment due to lack of efficacy. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-08-09 | Autifony Therapeutics Limited | Autifony Announces Results from Completed CLARITY-1, Phase IIa Trial of AUT00063 in Age-related Hearing Loss autifony.com ↗ |
| 2016-07-06 | Autifony Therapeutics Limited | Autifony Therapeutics initiates QuicK+fire, a pilot study of AUT00063 in adult cochlear implant users autifony.com ↗ |
| 2016-04-28 | Autifony Therapeutics Limited | Update from Autifony Therapeutics’ QUIET-1 tinnitus clinical trial autifony.com ↗ |
| 2015-10-13 | Autifony Therapeutics Limited | Update from Autifony Therapeutics’ QUIET-1 clinical trial autifony.com ↗ |
| 2013-06-04 | Autifony Therapeutics Limited | Autifony Therapeutics Initiates Phase I Study for Lead Product, AUT00063, for the Treatment of Hearing Loss and Tinnitus and Tops Up Series A Financing with Further 5.5 million Investment autifony.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AUT00063 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02345031 ↗ |
| Route | Oral | “800 mg orally, once a day, for 4 weeks” NCT02315508 ↗ |