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Morphine Sulfate Sustained-Release Tablet
Morphine Sulfate Sustained-Release Tablet is a Opioid Small molecule drug developed by Mundipharma (China) Pharmaceutical Co. Ltd. It is currently in Phase 3 development for Moderate to severe pain, Severe pain in cancer patients.
Morphine sulfate works by binding to opioid receptors in the brain and spinal cord, producing analgesia and altering emotional responses to pain.
Morphine sulfate works by binding to opioid receptors in the brain and spinal cord, producing analgesia and altering emotional responses to pain. Used for Moderate to severe pain, Severe pain in cancer patients.
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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 | Morphine Sulfate Sustained-Release Tablet |
|---|---|
| Sponsor | Mundipharma (China) Pharmaceutical Co. Ltd |
| Drug class | Opioid |
| Target | mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Morphine sulfate is a mu-opioid receptor agonist that activates the G-protein coupled receptor, leading to the inhibition of adenylate cyclase and a decrease in the release of neurotransmitters involved in pain perception. This results in analgesia and a reduction in emotional responses to pain.
Approved indications
- Moderate to severe pain
- Severe pain in cancer patients
Common side effects
- Nausea
- Vomiting
- Constipation
- Dizziness
- Somnolence
Key clinical trials
- 3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain (PHASE2)
- 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)
- Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report (NA)
- Dosing Intervals of Opioid Medication for Chronic Pain (PHASE4)
- Morphine for Treatment of Dyspnea in Patients With COPD (PHASE4)
- A Study to Evaluate Buprenorphine Transdermal Patch in Chinese Subjects With Moderate to Severe Chronic Cancer Pain (PHASE3)
- Efficacy and Safety of Postoperative Intravenous Parecoxib Sodium Followed by Oral Celecoxib in Osteoarthritis Patients (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:
- Morphine Sulfate Sustained-Release Tablet CI brief — competitive landscape report
- Morphine Sulfate Sustained-Release Tablet updates RSS · CI watch RSS
- Mundipharma (China) Pharmaceutical Co. Ltd portfolio CI
Frequently asked questions about Morphine Sulfate Sustained-Release Tablet
What is Morphine Sulfate Sustained-Release Tablet?
How does Morphine Sulfate Sustained-Release Tablet work?
What is Morphine Sulfate Sustained-Release Tablet used for?
Who makes Morphine Sulfate Sustained-Release Tablet?
What drug class is Morphine Sulfate Sustained-Release Tablet in?
What development phase is Morphine Sulfate Sustained-Release Tablet in?
What are the side effects of Morphine Sulfate Sustained-Release Tablet?
What does Morphine Sulfate Sustained-Release Tablet target?
Related
- Drug class: All Opioid drugs
- Target: All drugs targeting mu-opioid receptor
- Manufacturer: Mundipharma (China) Pharmaceutical Co. Ltd — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate to severe pain
- Indication: Drugs for Severe pain in cancer patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing