Drug

Tapentadol

Regulatory activity · MHRA

Emerging researchLate-stage development

Also known as Nucynta, PHENOL, 3-((1R,2R)-3-(DIMETHYLAMINO)-1-ETHYL-2-METHYLPROPYL)-.

RxNorm787390 ChEMBLCHEMBL1201776UNIIH8A007M585

Research papers

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Role of Preoperative Tapentadol in Reduction of Perioperative Analgesic Requirement After Breast Conservative Surgery in Cancer Patients.

Clinical trial2025-10-10Completed · ClinicalTrials.gov

Multimodal Analgesia in TKA. The Role of Tapentadol

Clinical trial2025-05-01Primary completion · ClinicalTrials.gov

Management of Postsurgical Pain After Cardiac Operations: Comparison of Tapentadol and Tramadol Analgesia

Clinical trial2024-12-31Primary completion · ClinicalTrials.gov

Oral Premedication With Tapentadol Versus Pregabalin for Acute Postoperative Pain in Lower Limb Surgery Under Neuraxial Anesthesia: A Pilot Randomized Controlled Trial

Clinical trial2024-07-05Completed · ClinicalTrials.gov

Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Unilateral Total Knee Arthroplasty- A Randomised, Double Blind, Active Control, Clinical Trial

Clinical trial2020-05-19Completed · ClinicalTrials.gov

Open-label Evaluation of the Pharmacokinetic Profile, Safety, and Efficacy of Tapentadol Oral Solution for the Treatment of Post-surgical Pain in Children and Adolescents Aged From 2 Years to Less Than 18 Years.

Clinical trial2019-11-04Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.

Clinical trial2019-10-28Results posted · ClinicalTrials.gov

An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Pain Due to Osteoarthritis of the Knee Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

Clinical trial2019-10-21Results posted · ClinicalTrials.gov

Pharmacokinetics, safety, and efficacy of tapentadol oral solution for treating moderate to severe pain in pediatric patients.

Research2019-05-31Journal of pain research

A Comparison of Analgesic and Respiratory Effects From Tapentadol Versus Oxycodone After Laparoscopic Hysterectomy.

Clinical trial2019-02-28Completed · ClinicalTrials.gov

Drug Safety Update: Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines

Regulatory2019-01-09MHRA

Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, phase 3b study.

Research2012-06-15Journal of pain research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Tapentadol

Aliases & brands

NucyntaPHENOL, 3-((1R,2R)-3-(DIMETHYLAMINO)-1-ETHYL-2-METHYLPROPYL)-

RxNorm CUI

787390

ChEMBL ID

CHEMBL1201776

UNII

H8A007M585

Regulatory jurisdictions

mhra

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2019-01-09Safety communicationSafety

Drug Safety Update: Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).