Tapentadol
- Generic Name
- Tapentadol
- Brand Names
- Nucynta
- Drug Type
- Small Molecule
- Chemical Formula
- C14H23NO
- CAS Number
- 175591-23-8
- Unique Ingredient Identifier
- H8A007M585
Overview
Tapentadol is a centrally-acting synthetic analgesic with a dual mechanism of action. It is a mu-opioid receptor agonist that also inhibits norepinephrine reuptake. Tapentadol was first approved by the FDA on November 20, 2008. The extended-release formulation of tapentadol was also approved by the FDA on August 26, 2011. Used in the management of pain, tapentadol is typically reserved for patients who have limited alternative treatment options.
Background
Tapentadol is a centrally-acting synthetic analgesic with a dual mechanism of action. It is a mu-opioid receptor agonist that also inhibits norepinephrine reuptake. Tapentadol was first approved by the FDA on November 20, 2008. The extended-release formulation of tapentadol was also approved by the FDA on August 26, 2011. Used in the management of pain, tapentadol is typically reserved for patients who have limited alternative treatment options.
Indication
用于治疗严重到需要阿片类镇痛剂且替代治疗不充分的急性疼痛。
Associated Conditions
- Diabetic Peripheral Neuropathic Pain (DPN)
- Severe Acute Pain
- Severe Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/21 | Phase 4 | Recruiting | |||
2023/08/21 | Phase 4 | Completed | Kempegowda Institute of Medical Sciences, Bangalore | ||
2019/06/10 | Phase 1 | Completed | |||
2019/05/20 | Phase 1 | Completed | |||
2018/07/27 | Phase 4 | Completed | All India Institute of Medical Sciences, Bhubaneswar | ||
2017/11/24 | Not Applicable | Completed | All India Institute of Medical Sciences, Bhubaneswar | ||
2017/10/19 | Phase 4 | Completed | Oslo University Hospital | ||
2017/04/20 | Phase 1 | Completed | Frederiksberg University Hospital | ||
2015/11/13 | Phase 3 | Completed | St. Olavs Hospital | ||
2014/08/20 | Phase 2 | Terminated |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
ORAL | 150 mg in 1 1 | 2023/12/20 | 24510-174 | ||
ORAL | 50 mg in 1 1 | 2023/12/21 | 24510-050 | ||
ORAL | 150 mg in 1 1 | 2018/09/24 | 69865-250 | ||
ORAL | 100 mg in 1 1 | 2018/09/24 | 69865-245 | ||
ORAL | 100 mg in 1 1 | 2023/12/21 | 24510-100 | ||
ORAL | 50 mg in 1 1 | 2011/03/01 | 21695-069 | ||
ORAL | 75 mg in 1 1 | 2018/09/30 | 69865-220 | ||
ORAL | 75 mg in 1 1 | 2023/12/21 | 24510-075 | ||
ORAL | 250 mg in 1 1 | 2018/09/24 | 69865-265 | ||
ORAL | 75 mg in 1 1 | 2010/07/09 | 16590-889 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
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 |
|---|
No NMPA products found
No NMPA products found for this drug
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 |
|---|---|---|---|---|---|
165357 | Active | 2011/01/19 | tapentadol hydrochloride | ||
165310 | Active | 2010/11/22 | tapentadol hydrochloride | ||
165346 | Active | 2011/01/19 | tapentadol hydrochloride | ||
165347 | Active | 2011/01/19 | tapentadol hydrochloride | ||
165317 | Active | 2010/11/22 | tapentadol hydrochloride | ||
229737 | Active | 2015/09/24 | tapentadol hydrochloride | ||
165356 | Active | 2011/01/19 | tapentadol hydrochloride | ||
165332 | Active | 2011/01/19 | tapentadol hydrochloride | ||
165318 | Active | 2010/11/22 | tapentadol hydrochloride |