Drugs / ZYN002
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06930872 | Jun → Oct 2025 | — | Harmony Biosciences Management, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05149898 | Feb 2020 → Nov 2022 | 22q11.2 deletion syndrome | Harmony Biosciences Management, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03614663 | Jun 2018 → Jun 2020 | fragile X syndrome | Zynerba Pharmaceuticals, Inc. | Completed | Mixed |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT04977986 | Sep 2021 → Aug 2025 | fragile X syndrome | Harmony Biosciences Management, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-09-24 | Harmony Biosciences Management, Inc. | Results Harmony Biosciences Provides Update From Its Phase 3 RECONNECT Study of ZYN002 in Fragile X Syndrome harmonybiosciences.com ↗
The RECONNECT Study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate. |
| 2025-04-08 | Harmony Biosciences Management, Inc. | Results Harmony Biosciences Presents Promising Open-Label Extension Data of ZYN002 in Fragile X Syndrome harmonybiosciences.com ↗
The data showed clinically meaningful improvements in irritability-related symptoms prevalent in individuals with FXS. |
| 2023-12-05 | Harmony Biosciences Management, Inc. | Results HARMONY BIOSCIENCES TO PRESENT RESULTS FROM BEHAVIORAL STUDY IN 22Q11.2 DELETION SYNDROME AT AMERICAN COLLEGE OF NEUROPSYCHOPHARMACOLOGY ANNUAL MEETING harmonybiosciences.com ↗
This framework proposes endpoint measures to assess the treatment of behavioral symptoms associated with the condition, which currently lacks FDA-approved treatments and affects approximately 80,000 individuals in the U.S. and 129,000 in the EU and UK . |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-24 | Harmony Biosciences Management, Inc. | Harmony Biosciences Provides Update From Its Phase 3 RECONNECT Study of ZYN002 in Fragile X Syndrome harmonybiosciences.com ↗ |
| 2025-04-08 | Harmony Biosciences Management, Inc. | Harmony Biosciences Presents Promising Open-Label Extension Data of ZYN002 in Fragile X Syndrome harmonybiosciences.com ↗ |
| 2023-12-05 | Harmony Biosciences Management, Inc. | HARMONY BIOSCIENCES TO PRESENT RESULTS FROM BEHAVIORAL STUDY IN 22Q11.2 DELETION SYNDROME AT AMERICAN COLLEGE OF NEUROPSYCHOPHARMACOLOGY ANNUAL MEETING harmonybiosciences.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZYN002 | “ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)” NCT06930872 ↗ |
| Known as | cannabidiol | “DESIGN: CONNECT-FX was a double-blind, randomized phase 3 trial assessing efficacy and safety of ZYN002, transdermal cannabidiol gel, for the treatment of behavioral symptoms...” PMID 36434514 ↗ Nov 20221“cannabidiol (CBD) administered as ZYN002” NCT05149898 ↗ |
| Known as | CBD | “cannabidiol (CBD) administered as ZYN002” NCT05149898 ↗ |
| Route | Other | “ZYN002 (transdermal)” NCT06930872 ↗ |