Drugs / Dexborneol
Dexborneol
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT07692399 | Jul 2026 → Dec 2027 expected | cerebral arteriopathy, autosomal dominant, with subcortical infarcts and leukoencephalopathy, type 1 | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05953103 | Jul 2023 → Apr 2025 | intracerebral hemorrhage | Simcere Pharmaceutical Co., Ltd | Terminated | No outcome recorded |
| Phase 2 | NCT05035953 | Sep 2021 → Sep 2023 | ischemic stroke | Huashan Hospital | Unknown | No outcome recorded |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT07040085 | Aug 2025 → Jun 2027 expected | stroke disorder | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06674460 | Aug 2025 → Oct 2027 expected | ischemic stroke | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05885919 | Jul 2023 → Dec 2024 | ischemic stroke | Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 3 | NCT05249920 | Mar 2022 → Feb 2023 | ischemic stroke | Beijing Tiantan Hospital | Completed | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07091994 | Aug → Dec 2026 expected | ischemic stroke | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06248242 | Jun 2021 → Jun 2024 | ischemic stroke | The Second Hospital of Hebei Medical University | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT05836766 Comparator | Jun 2023 → Jul 2024 | cerebral artery occlusion, ischemic stroke | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04950920 Comparator | Jun 2021 → Aug 2022 | ischemic stroke | Peking University Third Hospital | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-12-02 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory China NMPA approves Simcere’s Sanbexin® sublingual tablets for the treatment of Acute Ischemic Stroke simcere.com ↗
Simcere Pharmaceutical announced that Sanbexin ® sublingual tablets (generic name: edaravone and dexborneol sublingual tablets), an innovative drug for stroke, has been approved for marketing by the National Medical Products Administration. |
| 2024-09-03 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United Stated Food and Drug Administration simcere.com ↗
On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has been granted the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS). |
| 2022-12-02 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results PHASE III CLINICAL STUDY OF SANBEXIN SUBLINGUAL TABLETS ACHIEVED EXPECTED EFFICACY ENDPOINTS simcere.com ↗
Preliminary analysis shows that, compared with placebo, Sanbexin sublingual tablets have significantly improved the recovery of neurological function and ability to live independently following treatment in AIS patients, achieving expected efficacy endpoints with an excellent safety profile. |
| 2021-02-17 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results The Clinical Study Data for Sanbexin® was Published in the International Leading Neurology Medical Journal “STROKE” simcere.com ↗
The clinical trial data showed that edaravone and dexborneol concentrated solution for injection has better efficacy and comparable safety as compared to edaravone injection. |
| 2020-07-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) was Approved by NMPA on the Chinese Market simcere.com ↗
On July 30, 2020, the category Ⅰ innovative drug Sanbexin ® （edaravone and dexborneol concentrated solution for injection) developed by Simcere was approved to be sold in the market by the National Medical Products Administration (NMPA), with the approval reference number “National Medicine Zhunzi H20200007”. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-02 | Jiangsu Simcere Pharmaceutical Co., Ltd. | China NMPA approves Simcere’s Sanbexin® sublingual tablets for the treatment of Acute Ischemic Stroke simcere.com ↗ |
| 2024-09-03 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United Stated Food and Drug Administration simcere.com ↗ |
| 2022-12-02 | Jiangsu Simcere Pharmaceutical Co., Ltd. | PHASE III CLINICAL STUDY OF SANBEXIN SUBLINGUAL TABLETS ACHIEVED EXPECTED EFFICACY ENDPOINTS simcere.com ↗ |
| 2021-02-17 | Jiangsu Simcere Pharmaceutical Co., Ltd. | The Clinical Study Data for Sanbexin® was Published in the International Leading Neurology Medical Journal “STROKE” simcere.com ↗ |
| 2020-07-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) was Approved by NMPA on the Chinese Market simcere.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dexborneol | “Y-6 sublingual tablets (each tablet contains 25 mg cilostazol and 6 mg dexborneol) Manufacturer: Nanjing Neurodawn Pharmaceutical Co., Ltd.” NCT05836766 ↗9“each tablet of Y-6 contained 6 mg of dexborneol and 25 mg of cilostazol; Both groups took one tablet q12h for 28 days.” NCT07040085 ↗ “Sanbexin IV 37.5 mg (edaravone 30 mg + dexborneol 7.5 mg), intravenous, twice daily, for 14 consecutive days” NCT05953103 ↗ |
| Known as | Borneol d-form | ChEMBL registry synonym — accepted as the source's own label CHEMBL486208 ↗ |
| Known as | d-borneol | “Y-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg.” NCT04950920 ↗ |
| Known as | D-camphanol | ChEMBL registry synonym — accepted as the source's own label CHEMBL486208 ↗ |
| Known as | FEMA NO. 2157, (+)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL486208 ↗ |
| Action | Inhibit | “Dexborneol is anti-inflammatory and can effectively inhibit inflammatory cytokines.” NCT06248242 ↗ |
| Modality | Small molecule | — CHEMBL486208 ↗ |
| Route | Other | “Take Y-6 sublingual tablets for 28 days continuously.” NCT05836766 ↗ |