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Tramadol 5%
Tramadol 5% is a Opioid analgesic with monoamine reuptake inhibition Small molecule drug developed by Al-Azhar University. It is currently in Phase 3 development for Moderate to moderately severe pain, Chronic pain conditions. Also known as: Topical tramadol.
Tramadol is a synthetic opioid analgesic that binds to mu opioid receptors and inhibits the reuptake of norepinephrine and serotonin to produce pain relief.
Tramadol is a medication used to manage postoperative pain, as indicated by ClinicalTrials.gov. Its mechanism of action is not specified in the provided facts, but it is listed as an intervention in various studies on ClinicalTrials.gov and registered in ChEMBL.
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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).
| 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 | Tramadol 5% |
|---|---|
| Also known as | Topical tramadol |
| Sponsor | Al-Azhar University |
| Drug class | Opioid analgesic with monoamine reuptake inhibition |
| Target | Mu opioid receptor; norepinephrine and serotonin transporters |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Tramadol works through dual mechanisms: it acts as a weak mu opioid receptor agonist and also inhibits monoamine reuptake (norepinephrine and serotonin), enhancing descending pain inhibitory pathways. This combination provides analgesia with a lower abuse potential compared to pure opioids. The 5% formulation likely refers to a topical or oral solution concentration.
Approved indications
- Moderate to moderately severe pain
- Chronic pain conditions
Common side effects
- Nausea
- Dizziness
- Constipation
- Headache
- Somnolence
- Seizures (at high doses)
Key clinical trials
- Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty (PHASE4)
- QIPB in Inguinal Hernia (NA)
- Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery (NA)
- Management of Acute Appendicitis Pain in the Emergency Department
- Serratus Posterior Superior Intercostal Plane Block for Analgesia in Off-Pump Minimally Invasive CABG (NA)
- Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Inguinal Hernia Surgeries (NA)
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial (PHASE2)
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:
- Tramadol 5% CI brief — competitive landscape report
- Tramadol 5% updates RSS · CI watch RSS
- Al-Azhar University portfolio CI
Frequently asked questions about Tramadol 5%
What is Tramadol 5%?
How does Tramadol 5% work?
What is Tramadol 5% used for?
Who makes Tramadol 5%?
Is Tramadol 5% also known as anything else?
What drug class is Tramadol 5% in?
What development phase is Tramadol 5% in?
What are the side effects of Tramadol 5%?
What does Tramadol 5% target?
Related
- Drug class: All Opioid analgesic with monoamine reuptake inhibition drugs
- Target: All drugs targeting Mu opioid receptor; norepinephrine and serotonin transporters
- Manufacturer: Al-Azhar University — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate to moderately severe pain
- Indication: Drugs for Chronic pain conditions
- Also known as: Topical tramadol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing