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Hydromorphone HCI OROS
μ-opioid receptor agonist
μ-opioid receptor agonist Used for Moderate to severe pain.
At a glance
| Generic name | Hydromorphone HCI OROS |
|---|---|
| Sponsor | Janssen Korea, Ltd., Korea |
| Drug class | Opioid analgesic |
| Target | μ-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain management |
| Phase | Phase 2 |
Mechanism of action
Hydromorphone acts as a potent agonist at the μ-opioid receptor, producing analgesia and euphoria.
Approved indications
- Moderate to severe pain
Common side effects
- Nausea
- Vomiting
- Constipation
- Dizziness
- Somnolence
Key clinical trials
- A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain (PHASE1)
- Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
- A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis (PHASE3)
- A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain (PHASE3)
- An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg (PHASE1)
- Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain (PHASE3)
- An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release) (PHASE3)
- A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain (PHASE2)
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:
- Hydromorphone HCI OROS CI brief — competitive landscape report
- Hydromorphone HCI OROS updates RSS · CI watch RSS
- Janssen Korea, Ltd., Korea portfolio CI