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IR morphine sulphate
IR morphine sulphate is a Small molecule drug developed by Mundipharma Research Limited. It is currently in Phase 1 development. Also known as: IR morphine sulphate 10 mg/mL solution.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | IR morphine sulphate |
|---|---|
| Also known as | IR morphine sulphate 10 mg/mL solution |
| Sponsor | Mundipharma Research Limited |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
- A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS) (PHASE3)
- A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy (PHASE3)
- A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103) (PHASE1)
- A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104) (PHASE1)
- Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users (PHASE4)
- Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation (PHASE1)
- Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IR morphine sulphate CI brief — competitive landscape report
- IR morphine sulphate updates RSS · CI watch RSS
- Mundipharma Research Limited portfolio CI
Frequently asked questions about IR morphine sulphate
What is IR morphine sulphate?
Who makes IR morphine sulphate?
Is IR morphine sulphate also known as anything else?
What development phase is IR morphine sulphate in?
Related
- Manufacturer: Mundipharma Research Limited — full pipeline
- Also known as: IR morphine sulphate 10 mg/mL solution
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing