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Tapentadol ER (CG5503)
Tapentadol ER is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor.
Tapentadol ER is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor. Used for Chronic pain, Acute pain.
At a glance
| Generic name | Tapentadol ER (CG5503) |
|---|---|
| Also known as | CG5503 |
| Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Drug class | mu-opioid receptor agonist and norepinephrine reuptake inhibitor |
| Target | mu-opioid receptor, norepinephrine transporter |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Tapentadol ER works by activating the mu-opioid receptor, which is responsible for pain relief, and inhibiting the reuptake of norepinephrine, a neurotransmitter that also contributes to pain relief. This dual mechanism of action provides effective pain relief with a lower risk of opioid-related side effects.
Approved indications
- Chronic pain
- Acute pain
Common side effects
- Nausea
- Dizziness
- Headache
- Fatigue
- Constipation
Key clinical trials
- A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine (PHASE3)
- A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee (PHASE3)
- An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR) (PHASE4)
- A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain (PHASE3)
- Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
- Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain (PHASE3)
- An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain (PHASE3)
- A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain (PHASE3)
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 |
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