Drugs / AK0901
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06359899 | May 2024 → Jan 2025 | attention deficit-hyperactivity disorder | Shanghai Ark Biopharmaceutical Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-06-16 | Ark Biosciences Pty Ltd. | Regulatory 爱科百发用于治疗注意缺陷多动障碍新药爱智达®的上市申请获受理并纳入优先审评 arkbiosciences.com ↗
爱智达 ® 的上市申请获国家药监局受理并纳入优先审评，是中国ADHD治疗领域的重要突破。 |
| 2025-03-24 | Ark Biosciences Pty Ltd. | Results 爱科百发宣布用于治疗注意缺陷多动障碍新药爱智达™的Ⅲ期临床研究顺利完成 arkbiosciences.com ↗
研究结果显示达到主要终点和关键次要终点，与安慰剂相比在所有访视点上均取得了具有统计学意义的显著改善。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-06-16 | Ark Biosciences Pty Ltd. | 爱科百发用于治疗注意缺陷多动障碍新药爱智达®的上市申请获受理并纳入优先审评 arkbiosciences.com ↗ |
| 2025-03-24 | Ark Biosciences Pty Ltd. | 爱科百发宣布用于治疗注意缺陷多动障碍新药爱智达™的Ⅲ期临床研究顺利完成 arkbiosciences.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AK0901 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06359899 ↗ |
| Route | Oral | “Route of Administration: Oral” NCT06359899 ↗ |