Drugs / HSK16149
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07453862 | Mar 2026 → Jun 2027 expected | restless legs syndrome | Beijing Friendship Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT05881811 | Mar → Apr 2023 | postherpetic neuralgia | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05916573 | Dec 2022 → Feb 2023 | impaired renal function disease | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04841720 | Apr → Jun 2021 | diabetic polyneuropathy | Haisco Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07330648 | Oct 2025 → Jan 2027 expected | generalized anxiety disorder | Anhui Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06766916 | May 2025 → Nov 2026 expected | neuropathy, painful | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06490484 | Apr → Jul 2024 | diabetic polyneuropathy | Haisco Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT06007066 | Mar → Jun 2023 | — | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05763550 | Feb → Jun 2023 | neuralgia | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04647773 | Dec 2020 → Nov 2022 | diabetic polyneuropathy | Haisco Pharmaceutical Group Co., Ltd. | Unknown | Met primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT06422117 | May 2024 → Jul 2027 expected | neurological pain disorder | Haisco Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05890053 | Feb 2022 → Jul 2023 | neuropathy, painful | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05140863 | Nov 2021 → Dec 2022 | postherpetic neuralgia | Haisco Pharmaceutical Group Co., Ltd. | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07699770 | Jun 2026 → Oct 2027 expected | neuromyelitis optica, neuropathy, painful | Tang-Du Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07483398 | Mar 2026 → Aug 2027 expected | Parkinson disease | Guangdong Provincial People's Hospital | Active not recruiting | No outcome recorded |
| Phase not applicable3 trials · 1 met primary | ||||||
| — | NCT07307976 | Dec 2025 → Sep 2027 expected | herpes zoster | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT07196657 | Sep 2025 → Jun 2027 expected | fibromyalgia | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06122012 | May 2023 → Apr 2024 | diabetic polyneuropathy | Haisco Pharmaceutical Group Co., Ltd. | Unknown | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07859111 Comparator | Aug 2026 → Aug 2028 expected | neuropathy, painful | Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-05-12 | Haisco Pharmaceutical Group Co., Ltd. | Regulatory 2026.5.12 海思科创新药克利加巴林拟纳入优先评审 haisco.com ↗
5月9日，国家药品监督管理局药品审评中心显示，海思科克利加巴林（HSK16149）拟纳入优先审评，用于神经病理性疼痛。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-05-12 | Haisco Pharmaceutical Group Co., Ltd. | 2026.5.12 海思科创新药克利加巴林拟纳入优先评审 haisco.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HSK16149 | “Efficacy and Safety of Crisugabalin (HSK16149) in Adults with Postherpetic
Neuralgia: A Phase 3 Randomized Clinical Trial.” PMID 39320907 ↗ Nov 202411“The Efficacy and Safety of Crisugabalin (HSK16149) in Fibromyalgia Patients” PMID 41800444 ↗ Mar 2026 |
| Known as | Crisugabalin | “OBJECTIVE: To investigate the efficacy and safety of crisugabalin, an oral calcium channel α2δ-1 subunit ligand, for postherpetic neuralgia.” PMID 39320907 ↗ Nov 2024 |
| Route | Oral | “oral HSK16149 capsules 80 mg BID” NCT04841720 ↗ |