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Targinact
Targinact is a Small molecule drug developed by University of Edinburgh. It is currently in Phase 3 development. Also known as: Oxycodone-Naloxone.
Targinact, also known as oxycodone/naloxone prolonged release tablets, is a combination pain medication used to treat chronic severe pain, cancer pain, and other conditions. It is available as modified-release tablets administered by mouth.
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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 | Targinact |
|---|---|
| Also known as | Oxycodone-Naloxone |
| Sponsor | University of Edinburgh |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section (PHASE4)
- Targin® for Chronic Pain Management in Patients With Spinal Cord Injury (PHASE4)
- A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain (PHASE3)
- A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy (PHASE3)
- Treatment of Chronic Pain From Osteoarthritis (PHASE4)
- A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery (PHASE3)
- To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain (PHASE2, PHASE3)
- GREAT - Good Response With Appropriate Treatment
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:
- Targinact CI brief — competitive landscape report
- Targinact updates RSS · CI watch RSS
- University of Edinburgh portfolio CI
Frequently asked questions about Targinact
What is Targinact?
Who makes Targinact?
Is Targinact also known as anything else?
What development phase is Targinact in?
Related
- Manufacturer: University of Edinburgh — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Oxycodone-Naloxone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing