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Immediate release morphine sulphate
Immediate release morphine sulphate is a Opioid analgesic Small molecule drug developed by Archimedes Development Ltd. It is currently in Phase 3 development for Acute pain management, Moderate to severe pain. Also known as: IRMS, Morphine Solution.
Morphine sulphate binds to opioid receptors in the central and peripheral nervous system to produce analgesia and sedation.
Immediate release morphine sulphate is used to treat pain, particularly cancer pain, and opioid-induced constipation.
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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 | Immediate release morphine sulphate |
|---|---|
| Also known as | IRMS, Morphine Solution |
| Sponsor | Archimedes Development Ltd |
| Drug class | Opioid analgesic |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain management |
| Phase | Phase 3 |
Mechanism of action
Morphine is a mu-opioid receptor agonist that modulates pain perception by binding to opioid receptors in the brain, spinal cord, and peripheral tissues. This binding inhibits the transmission of pain signals and produces analgesic, euphoric, and sedative effects. Immediate-release formulations are designed for rapid onset of action, typically used for acute pain management.
Approved indications
- Acute pain management
- Moderate to severe pain
Common side effects
- Constipation
- Nausea
- Drowsiness
- Dizziness
- Respiratory depression
- Dependence/tolerance
Key clinical trials
- Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain (PHASE1)
- A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy (PHASE3)
- Opioid/Benzodiazepine Polydrug Abuse: Aim 3 (PHASE2)
- Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery (PHASE4)
- Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement) (PHASE4)
- IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration (PHASE3)
- Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain (PHASE4)
- Rebound Pain Following Regional Anaesthesia for Ankle Fracture Surgery (PHASE4)
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:
- Immediate release morphine sulphate CI brief — competitive landscape report
- Immediate release morphine sulphate updates RSS · CI watch RSS
- Archimedes Development Ltd portfolio CI
Frequently asked questions about Immediate release morphine sulphate
What is Immediate release morphine sulphate?
How does Immediate release morphine sulphate work?
What is Immediate release morphine sulphate used for?
Who makes Immediate release morphine sulphate?
Is Immediate release morphine sulphate also known as anything else?
What drug class is Immediate release morphine sulphate in?
What development phase is Immediate release morphine sulphate in?
What are the side effects of Immediate release morphine sulphate?
What does Immediate release morphine sulphate target?
Related
- Drug class: All Opioid analgesic drugs
- Target: All drugs targeting Mu-opioid receptor (μ-OR)
- Manufacturer: Archimedes Development Ltd — full pipeline
- Therapeutic area: All drugs in Pain management
- Indication: Drugs for Acute pain management
- Indication: Drugs for Moderate to severe pain
- Also known as: IRMS, Morphine Solution
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing