Drugs / AEF0117
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05554926 | Dec 2022 → Feb 2023 | hallucinogen abuse | Aelis Farma | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05322941 | May 2022 → Apr 2024 | cannabis dependence | Aelis Farma | Completed | Missed primary |
| Phase 2 | NCT03717272 | Oct 2018 → Jul 2020 | cannabis dependence | Aelis Farma | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03443895 Comparator | Jan → May 2018 | — | Aelis Farma | Completed | No outcome recorded |
| Phase 1 | NCT03325595 Comparator | Apr 2017 → Feb 2018 | — | Aelis Farma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-03-27 | Aelis Farma | Results Final Phase 2B Results with AEF0117 in Cannabis Use Disorder (CUD) aelisfarma.com ↗
Press release to announce the Final Phase 2B Results with AEF0117 in Cannabis Use Disorder (CUD) published on March 26, 2025 |
| 2024-09-04 | Indivior Inc. | Results Indivior Provides Update on Aelis Farma's Clinical Phase 2B Study Results with AEF0117 in Participants with Cannabis Use Disorder indivior.com ↗
Primary and Secondary End Points of the Study were Not Met |
| 2024-09-04 | Indivior Inc. | Results Indivior | Indivior Provides Update on Aelis Farma's Clinical Phase 2B Study Results with AEF0117 in Participants with Cannabis Use Disorder indivior.com ↗
Although these results are disappointing, they indicate that significant work remains to be done to understand subpopulations of patients with CUD, specifically those with severe CUD. |
| 2024-09-04 | Aelis Farma | Results Results of the clinical Phase 2B Study with AEF0117 in Cannabis Use Disorder aelisfarma.com ↗
Press release to announce the Results of the clinical Phase 2B Study with AEF0117 published on September 4, 2024 |
| 2023-07-05 | Aelis Farma | Results Aelis Farma receives a positive recommendation from the DSMB to continue, with no modification to the protocol, the phase 2b clinical study with AEF0117 in cannabis addiction aelisfarma.com ↗
Following the meeting, the committee observed no serious adverse events or significant events associated with the treatment and recommended that the study be continued without any modifications to the protocol. |
| 2023-06-08 | Aelis Farma | Results Nature Medicine Publishes Discovery of New Pharmacological Class by Aelis Farma, Phase 2a Study of First Drug Candidate for Cannabis Use Disorder aelisfarma.com ↗ |
| 2018-07-01 | Aelis Farma | Results Aelis Farma successfully completes the phase I trials with AEF0117 aelisfarma.com ↗
These studies confirm the excellent safety profile of AEF0117 already observed in animals. |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AEF0117 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03717272 ↗ |
| Action | Inhibit | “AEF0117, the first of a new pharmacological class, is a signaling-specific inhibitor of the cannabinoid receptor 1 (CB1).” PMID 37291212 ↗ Jun 2023 |
| Route | Oral | “single oral doses of AEF0117 in healthy adult male and female subjects” NCT03325595 ↗ |