Sufentanil
- Generic Name
- Sufentanil
- Brand Names
- Dsuvia, Sufenta, Dzuveo
- Drug Type
- Small Molecule
- Chemical Formula
- C22H30N2O2S
- CAS Number
- 56030-54-7
- Unique Ingredient Identifier
- AFE2YW0IIZ
Overview
Sufentanil is an opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent. It is administered by the intravenous, epidural and sublingual routes. Also known as Dsuvia, the sublingual form is used for the management of acute pain in adults that is severe to warrant the use of an opioid analgesic in certified medically supervised healthcare settings, including hospitals, surgical centers, and emergency departments . Consideration may be made in the future for the use of the sublingual form in the US military in cases where analgesia is required immediately . The sublingual form, manufactured by AcelRx Pharmaceuticals, Inc. (AcelRx), was approved on November 2, 2018 . This route of administration is intended to be a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage acute pain without difficult intravenous or epidural administration , .
Background
Sufentanil is an opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent. It is administered by the intravenous, epidural and sublingual routes. Also known as Dsuvia, the sublingual form is used for the management of acute pain in adults that is severe to warrant the use of an opioid analgesic in certified medically supervised healthcare settings, including hospitals, surgical centers, and emergency departments . Consideration may be made in the future for the use of the sublingual form in the US military in cases where analgesia is required immediately . The sublingual form, manufactured by AcelRx Pharmaceuticals, Inc. (AcelRx), was approved on November 2, 2018 . This route of administration is intended to be a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage acute pain without difficult intravenous or epidural administration , .
Indication
The indications for this drug are as follows:
Associated Conditions
- Acute Pain
- Severe Acute Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/12 | Phase 4 | Not yet recruiting | |||
2025/05/25 | Not Applicable | Recruiting | |||
2025/05/06 | Phase 4 | Not yet recruiting | Qianfoshan Hospital | ||
2025/04/08 | Phase 3 | Recruiting | University Hospital, Clermont-Ferrand | ||
2025/03/25 | Phase 4 | Recruiting | |||
2025/02/05 | Not Applicable | Not yet recruiting | Second Hospital of Shanxi Medical University | ||
2024/08/26 | Early Phase 1 | Not yet recruiting | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | ||
2024/07/31 | Phase 4 | Not yet recruiting | Xiangya Hospital of Central South University | ||
2024/07/23 | N/A | Recruiting | Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. | ||
2024/04/25 | Not Applicable | Completed | Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
INTRAVENOUS, EPIDURAL | 50 ug in 1 mL | 2014/03/31 | 17478-050 | ||
EPIDURAL, INTRAVENOUS | 50 ug in 1 mL | 2023/07/17 | 0409-3382 | ||
EPIDURAL, INTRAVENOUS | 0.05 mg in 1 mL | 2018/09/17 | 0641-6111 | ||
EPIDURAL, INTRAVENOUS | 0.05 mg in 1 mL | 2018/09/17 | 0641-6112 | ||
EPIDURAL, INTRAVENOUS | 0.05 mg in 1 mL | 2018/09/17 | 0641-6110 | ||
AcelRx Pharmaceuticals, Inc. | SUBLINGUAL | 30 ug in 1 1 | 2023/12/18 | 61621-430 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|---|---|---|---|---|---|---|---|
EMEA/H/C/004335 | France | N/A | Authorised | 2018/06/25 | 2018/04/26 | 8 |
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
|---|
No HSA products found
No HSA products found for this drug
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H20203652 | 注射剂 | N/A | 5ml:250μg(按C22H30N2O2S计) | Chemical Drug | Approved | 2020/12/08 | Domestic | ||
国药准字H20203713 | 注射剂 | N/A | 按C22H30N2O2S计2ml:100ug | Chemical Drug | Approved | 2020/12/25 | Domestic | ||
国药准字H20203712 | 注射剂 | N/A | 按C22H30N2O2S计1ml:50ug | Chemical Drug | Approved | 2020/12/25 | Domestic | ||
国药准字H20054171 | 注射剂 | N/A | 1ml:50μg(按C22H30N2O2S计) | Chemical Drug | Approved | 2020/06/10 | Domestic | ||
国药准字H20203650 | 注射剂 | N/A | 1ml:50μg(按C22H30N2O2S计) | Chemical Drug | Approved | 2020/12/08 | Domestic | ||
H20150126 | 注射剂 | 舒芬尼 | 1ml:75μg(相当于舒芬太尼50μg) | Chemical Drug | Expired | 2015/03/15 | Import | ||
国药准字H20054172 | 注射剂 | N/A | 2ml∶100μg(按C22H30N2O2S计) | Chemical Drug | Approved | 2020/06/10 | Domestic | ||
H20150125 | 注射剂 | 舒芬尼 | 5ml:375μg(相当于舒芬太尼250μg) | Chemical Drug | Expired | 2015/03/15 | Import | ||
国药准字H20054256 | 注射剂 | N/A | 5ml∶250μg(按C22H30N2O2S计) | Chemical Drug | Approved | 2020/07/16 | Domestic | ||
国药准字H20203651 | 注射剂 | N/A | 2ml:100μg(按C22H30N2O2S计) | Chemical Drug | Approved | 2020/12/08 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
|---|
No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
|---|
No TGA products found
No TGA products found for this drug