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Tapentadol ER (CG5503) — Competitive Intelligence Brief
phase 3
mu-opioid receptor agonist and norepinephrine reuptake inhibitor
mu-opioid receptor, norepinephrine transporter
Pain
Small molecule
Live · refreshed every 30 min
Target snapshot
Tapentadol ER (CG5503) (Tapentadol ER (CG5503)) — Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Tapentadol ER is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor.
Comparator set (4 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Tapentadol ER (CG5503) TARGET | Tapentadol ER (CG5503) | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | phase 3 | mu-opioid receptor agonist and norepinephrine reuptake inhibitor | mu-opioid receptor, norepinephrine transporter | |
| dexketoprofen trometamol + tramadol hydrochloride | dexketoprofen trometamol + tramadol hydrochloride | Kavaklıdere Umut Hospital | marketed | NSAID + opioid analgesic combination | COX-1/COX-2 (dexketoprofen); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol) | |
| Ropivacaine + Tramadol | Ropivacaine + Tramadol | Aga Khan University | marketed | Local anesthetic + opioid analgesic combination | Voltage-gated sodium channels (ropivacaine); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol) | |
| lidocaine+systemic tramadol | lidocaine+systemic tramadol | Bagcilar Training and Research Hospital | phase 3 | Local anesthetic and weak opioid agonist | Mu-opioid receptor, Norepinephrine transporter | |
| CG5503 IR; tapentadol | CG5503 IR; tapentadol | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | phase 3 | Mu-opioid receptor agonist and norepinephrine reuptake inhibitor | Mu-opioid receptor (OPRM1); norepinephrine transporter (SLC6A2) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (mu-opioid receptor agonist and norepinephrine reuptake inhibitor class)
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Tapentadol ER (CG5503) — Competitive Intelligence Brief. https://druglandscape.com/ci/tapentadol-er-cg5503. Accessed 2026-05-16.
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