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MR308
MR308 is a P2X3 receptor antagonist Small molecule drug developed by Mundipharma Research GmbH & Co KG. It is currently in Phase 3 development for Chronic cough, Neuropathic pain. Also known as: Tramadol/Celecoxib, Tramadol, Celecoxib, Placebos.
MR308 is a selective antagonist of the P2X3 receptor that reduces pain signaling in sensory neurons.
MR308 is a medication being studied for the treatment of acute pain, with a randomized, double-blind, multicenter study (NCT03062644) comparing its efficacy and safety to tramadol and a placebo. The study, known as STARDOM2, aims to evaluate the effectiveness and safety of MR308 in managing acute pain.
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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 | MR308 |
|---|---|
| Also known as | Tramadol/Celecoxib, Tramadol, Celecoxib, Placebos |
| Sponsor | Mundipharma Research GmbH & Co KG |
| Drug class | P2X3 receptor antagonist |
| Target | P2X3 |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
P2X3 receptors are ion channels expressed on nociceptive nerve fibers that mediate pain transmission when activated by extracellular ATP. By blocking P2X3, MR308 reduces the excitability of pain-sensing neurons and dampens pain signal propagation to the central nervous system. This mechanism is particularly relevant for chronic pain conditions where ATP-mediated signaling contributes to persistent pain states.
Approved indications
- Chronic cough
- Neuropathic pain
Common side effects
- Taste disturbance
- Dizziness
- Headache
Key clinical trials
- Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2. (PHASE3)
- Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib). (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MR308 CI brief — competitive landscape report
- MR308 updates RSS · CI watch RSS
- Mundipharma Research GmbH & Co KG portfolio CI
Frequently asked questions about MR308
What is MR308?
How does MR308 work?
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Who makes MR308?
Is MR308 also known as anything else?
What drug class is MR308 in?
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What does MR308 target?
Related
- Drug class: All P2X3 receptor antagonist drugs
- Target: All drugs targeting P2X3
- Manufacturer: Mundipharma Research GmbH & Co KG — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Chronic cough
- Indication: Drugs for Neuropathic pain
- Also known as: Tramadol/Celecoxib, Tramadol, Celecoxib, Placebos
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing