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Morphine Sulfate Sustained-release Tablets
Morphine Sulfate Sustained-release Tablets is a Opioid analgesic Small molecule drug developed by Fujian Cancer Hospital. It is currently in Phase 3 development for Cancer pain management, Moderate to severe chronic pain in cancer patients.
Morphine sulfate binds to opioid receptors in the central nervous system to reduce pain perception and provide analgesia.
Morphine Sulfate Sustained-release Tablets are a type of medication classified as a mu opioid receptor agonist. They are used to treat various conditions, including cancer pain, chronic pain, and opioid-induced constipation, among others.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 Tablets |
|---|---|
| Sponsor | Fujian Cancer Hospital |
| Drug class | Opioid analgesic |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Oncology; Pain Management |
| Phase | Phase 3 |
Mechanism of action
Morphine is a mu-opioid receptor agonist that modulates pain signaling by binding to opioid receptors in the brain and spinal cord, reducing the transmission and perception of pain signals. The sustained-release formulation provides prolonged drug delivery over an extended period, allowing for less frequent dosing in chronic pain management. This formulation is particularly useful in cancer pain management where continuous analgesia is required.
Approved indications
- Cancer pain management
- Moderate to severe chronic pain in cancer patients
Common side effects
- Constipation
- Nausea
- Drowsiness/Sedation
- Dizziness
- Vomiting
- Respiratory depression
- Pruritus
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 Tablets CI brief — competitive landscape report
- Morphine Sulfate Sustained-release Tablets updates RSS · CI watch RSS
- Fujian Cancer Hospital portfolio CI
Frequently asked questions about Morphine Sulfate Sustained-release Tablets
What is Morphine Sulfate Sustained-release Tablets?
How does Morphine Sulfate Sustained-release Tablets work?
What is Morphine Sulfate Sustained-release Tablets used for?
Who makes Morphine Sulfate Sustained-release Tablets?
What drug class is Morphine Sulfate Sustained-release Tablets in?
What development phase is Morphine Sulfate Sustained-release Tablets in?
What are the side effects of Morphine Sulfate Sustained-release Tablets?
What does Morphine Sulfate Sustained-release Tablets target?
Related
- Drug class: All Opioid analgesic drugs
- Target: All drugs targeting Mu-opioid receptor (μ-OR)
- Manufacturer: Fujian Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Oncology; Pain Management
- Indication: Drugs for Cancer pain management
- Indication: Drugs for Moderate to severe chronic pain in cancer patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing