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Oral immediate-released morphine
Oral immediate-released morphine is a Opioid analgesic Small molecule drug developed by Fujian Cancer Hospital. It is currently in Phase 3 development for Cancer pain in patients with advanced malignancy, Moderate to severe acute and chronic pain.
Morphine binds to opioid receptors in the central nervous system to reduce pain perception and provide analgesia.
Oral immediate-release morphine is used to treat pain, including post-operative pain, hip injuries, and hip fractures. Its mechanism of action involves interacting with opioid receptors in the brain, although the exact details of this interaction are not specified in the provided facts.
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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 | Oral immediate-released morphine |
|---|---|
| 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 crosses the blood-brain barrier and acts on opioid receptors in the brain and spinal cord. This binding modulates pain signal transmission and produces analgesic effects. It is commonly used for moderate to severe pain management, particularly in cancer patients.
Approved indications
- Cancer pain in patients with advanced malignancy
- Moderate to severe acute and chronic pain
Common side effects
- Constipation
- Nausea
- Drowsiness
- Dizziness
- Vomiting
- Respiratory depression
- Dependence/tolerance
Key clinical trials
- Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain (PHASE1)
- Opioid/Benzodiazepine Polydrug Abuse: Aim 3 (PHASE2)
- Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery (PHASE4)
- IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration (PHASE3)
- Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints (EARLY_PHASE1)
- Is the Rate of Early Mobilisation in Hip Fracture Patients Using Alfentanil Better Than Standard Opioid Analgesia?
- A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104) (PHASE1)
- Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation (PHASE1)
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:
- Oral immediate-released morphine CI brief — competitive landscape report
- Oral immediate-released morphine updates RSS · CI watch RSS
- Fujian Cancer Hospital portfolio CI
Frequently asked questions about Oral immediate-released morphine
What is Oral immediate-released morphine?
How does Oral immediate-released morphine work?
What is Oral immediate-released morphine used for?
Who makes Oral immediate-released morphine?
What drug class is Oral immediate-released morphine in?
What development phase is Oral immediate-released morphine in?
What are the side effects of Oral immediate-released morphine?
What does Oral immediate-released morphine 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 in patients with advanced malignancy
- Indication: Drugs for Moderate to severe acute and chronic pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing