Approval Probability
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tapentadol 25-mg TRF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol (CG5503) ER 25-mg TRF 50 mg TRF single oral dose |
| 002 | EXPERIMENTAL | tapentadol (CG5503) ER 50-mg TRF 50 mg TRF single oral dose |
| Name | Type | Description |
|---|---|---|
| tapentadol (CG5503) ER 25-mg TRF | DRUG | 50 mg TRF single oral dose |
| tapentadol (CG5503) ER 50-mg TRF | DRUG | 50 mg TRF single oral dose |
Inclusion Criteria: * Japanese participants who have resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report * Deemed healthy on the basis of prestudy physical examination, medical history ...
Tapentadol 25-mg TRF is a small-molecule drug candidate developed by Johnson & Johnson, which trades under the ticker JNJ. It is also known as tapentadol (CG5503) ER 25-mg TRF. The 25-mg TRF designation refers to a 25-milligram tablet formulation studied in a bioequivalence trial.
Tapentadol 25-mg TRF targets SLC6A2, the norepinephrine transporter, and OPRM1, the mu-opioid receptor. It is classified as an inhibitor. By acting at both of these targets, the molecule combines norepinephrine reuptake inhibition with mu-opioid receptor activity in a single small-molecule agent.
Johnson & Johnson, ticker JNJ, is the developer of tapentadol 25-mg TRF. The compound is also referred to as tapentadol (CG5503) ER 25-mg TRF. Johnson & Johnson has advanced the asset through early clinical testing.
Tapentadol 25-mg TRF is in Phase 1 development. It is an investigational drug candidate and has not been approved by the FDA. The program has one completed Phase 1 trial, and no trials are currently active.
Tapentadol 25-mg TRF has been studied in one completed Phase 1 trial, NCT01273506. That trial compared the bioequivalence of a 50-mg tapentadol (CG5503) dose given as two 25-mg tablets versus one 50-mg tablet. It enrolled 30 healthy male volunteers aged 20 years and older and used a randomized, controlled design.