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tapentadol IR
tapentadol IR is a centrally acting analgesic Small molecule drug developed by Ortho-McNeil Janssen Scientific Affairs, LLC. It is currently in Phase 3 development.
Tapentadol works through dual mechanisms: mu-opioid receptor agonism and norepinephrine reuptake inhibition to provide centrally-mediated analgesia.
Tapentadol IR is a small molecule used to treat various conditions, including chronic pain, low back pain, and osteoarthritis. It is available in capsule form and has been studied in clinical trials for its pharmacokinetic properties and interactions with other medications, such as omeprazole.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Ortho-McNeil Janssen Scientific Affairs, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | tapentadol IR |
|---|---|
| Sponsor | Ortho-McNeil Janssen Scientific Affairs, LLC |
| Drug class | centrally acting analgesic |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Tapentadol binds to mu-opioid receptors in the central nervous system to produce analgesic effects while simultaneously inhibiting norepinephrine reuptake. This dual mechanism provides pain relief through complementary pathways, potentially offering improved tolerability compared to pure opioid agonists.
Approved indications
Common side effects
Key clinical trials
- Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models (PHASE1)
- A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy (PHASE3)
- Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic (PHASE3)
- Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability. (PHASE3)
- Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol) (PHASE1)
- Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics (PHASE3)
- A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- tapentadol IR CI brief — competitive landscape report
- tapentadol IR updates RSS · CI watch RSS
- Ortho-McNeil Janssen Scientific Affairs, LLC portfolio CI
Frequently asked questions about tapentadol IR
What is tapentadol IR?
How does tapentadol IR work?
Who makes tapentadol IR?
What drug class is tapentadol IR in?
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Related
- Drug class: All centrally acting analgesic drugs
- Manufacturer: Ortho-McNeil Janssen Scientific Affairs, LLC — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing