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Tramadol (Ultram®)
Tramadol (Ultram®) is a Opioid analgesic Small molecule drug developed by Esteve Pharmaceuticals, S.A.. It is currently in Phase 3 development for Moderate to moderately severe pain, Severe pain.
Tramadol is a centrally acting opioid analgesic that works by binding to opioid receptors in the brain and spinal cord, reducing pain perception.
Tramadol, also known as Ultram, is a small molecule that acts as a mu opioid receptor agonist. It is used to treat various conditions, including pain, acute low back pain, and post-cesarean pain, among others.
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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 (Ultram®) |
|---|---|
| Sponsor | Esteve Pharmaceuticals, S.A. |
| Drug class | Opioid analgesic |
| Target | Opioid receptors |
| Modality | Small molecule |
| Therapeutic area | Pain management |
| Phase | Phase 3 |
Mechanism of action
Tramadol's mechanism of action involves the inhibition of the reuptake of norepinephrine and serotonin, as well as the activation of opioid receptors. This results in a decrease in the transmission of pain signals to the brain, leading to analgesia.
Approved indications
- Moderate to moderately severe pain
- Severe pain
Common side effects
- Nausea
- Dizziness
- Headache
- Somnolence
- Constipation
- Vomiting
- Fatigue
- Dry mouth
- Sweating
- Rash
Key clinical trials
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- Comparison of Postoperative Analgesic Efficacy of Interscalene and Suprascapular Blocks Used in Arthroscopic Shoulder Surgery
- Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain (NA)
- 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial (PHASE2)
- Efficacy of Intercostal CryoAnalgesia in Robotic Lung Resection (PHASE4)
- Ultrasound-Guided Regional Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy (NA)
- Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy (NA)
- Continue ESPB & Continue ESPB Combined With SAPB for Thoracotomy (NA)
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 (Ultram®) CI brief — competitive landscape report
- Tramadol (Ultram®) updates RSS · CI watch RSS
- Esteve Pharmaceuticals, S.A. portfolio CI
Frequently asked questions about Tramadol (Ultram®)
What is Tramadol (Ultram®)?
How does Tramadol (Ultram®) work?
What is Tramadol (Ultram®) used for?
Who makes Tramadol (Ultram®)?
What drug class is Tramadol (Ultram®) in?
What development phase is Tramadol (Ultram®) in?
What are the side effects of Tramadol (Ultram®)?
What does Tramadol (Ultram®) target?
Related
- Drug class: All Opioid analgesic drugs
- Target: All drugs targeting Opioid receptors
- Manufacturer: Esteve Pharmaceuticals, S.A. — full pipeline
- Therapeutic area: All drugs in Pain management
- Indication: Drugs for Moderate to moderately severe pain
- Indication: Drugs for Severe pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing