Drugs / KH001
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04804514 | Jun 2021 → Mar 2023 | dentin sensitivity | HysensBio Co., Ltd | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07434271 | Dec 2025 → May 2026 overdue | premature ejaculation | Kadence Bio | Recruiting | No outcome recorded |
| Phase 2 | NCT06580678 | Nov 2024 → May 2025 | dentin caries | Byoung-Moo Seo | Completed | No outcome recorded |
| Phase 2 | NCT06464939 | Oct 2024 → Dec 2025 | dentin sensitivity | HysensBio Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT06264453 | Mar → Sep 2024 | dentin sensitivity | HysensBio Co., Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-11-16 | Kadence Bio | Regulatory Kanna Health (now Kadence Bio) announces FDA and MHRA approvals to begin its Phase 1 clinical trial for the development of KH-001 as first FDA-approved treatment for premature ejaculation kadencebio.com ↗
The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Kanna Health’s (trading as Kadence Bio) Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to start participant enrollment in a Phase 1 first-in-human clinical trial investigating the Safety and Pharmacokinetics of KH-001 Besylate (KH-001) in Healthy Male Subjects. |
All press releases naming this drug 1 release
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 | KH001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06464939 ↗ |
| Known as | KH-001 besylate | “KH-001 besylate formulated as an orally disintegrating tablet (ODT)” NCT07434271 ↗ |
| Action | Inhibit | “KH-001, a selective serotonin transporter (SERT) inhibitor” NCT07434271 ↗ |
| Route | Other | “The study drug is applied to teeth” NCT04804514 ↗ |