Last reviewed · How we verify
Hydromorphone ER
Hydromorphone ER is a Opioid analgesic Small molecule drug developed by Shirley Ryan AbilityLab. It is currently FDA-approved for Chronic pain requiring continuous opioid therapy, Moderate to severe pain in opioid-tolerant patients. Also known as: Exalgo(hydromorphone HCl), CII (77605306), Dilaudid.
Hydromorphone ER is an opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and pain relief.
Hydromorphone ER is a small molecule medication used to treat acute severe pain. It is administered orally in extended-release form.
At a glance
| Generic name | Hydromorphone ER |
|---|---|
| Also known as | Exalgo(hydromorphone HCl), CII (77605306), Dilaudid |
| Sponsor | Shirley Ryan AbilityLab |
| Drug class | Opioid analgesic |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Hydromorphone is a semi-synthetic opioid that activates mu-opioid receptors throughout the brain and spinal cord, inhibiting pain signal transmission and modulating pain perception. The extended-release formulation provides sustained drug delivery over 24 hours, allowing for once or twice-daily dosing in chronic pain management. It is approximately 6-8 times more potent than morphine.
Approved indications
- Chronic pain requiring continuous opioid therapy
- Moderate to severe pain in opioid-tolerant patients
Common side effects
- Constipation
- Nausea
- Dizziness
- Somnolence
- Vomiting
- Headache
- Respiratory depression
Key clinical trials
- Oral Abuse Potential Study of Nalbuphine (PHASE1)
- Titration of Intravenous Hydromorphone (PHASE4)
- Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA (PHASE3)
- Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
- Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients (PHASE3)
- True Functional Restoration and Analgesia in Non-Radicular Low Back Pain (PHASE4)
- Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin) (PHASE4)
- Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
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 ER CI brief — competitive landscape report
- Hydromorphone ER updates RSS · CI watch RSS
- Shirley Ryan AbilityLab portfolio CI
Frequently asked questions about Hydromorphone ER
What is Hydromorphone ER?
How does Hydromorphone ER work?
What is Hydromorphone ER used for?
Who makes Hydromorphone ER?
Is Hydromorphone ER also known as anything else?
What drug class is Hydromorphone ER in?
What development phase is Hydromorphone ER in?
What are the side effects of Hydromorphone ER?
What does Hydromorphone ER target?
Related
- Drug class: All Opioid analgesic drugs
- Target: All drugs targeting Mu-opioid receptor (μ-OR)
- Manufacturer: Shirley Ryan AbilityLab — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Chronic pain requiring continuous opioid therapy
- Indication: Drugs for Moderate to severe pain in opioid-tolerant patients
- Also known as: Exalgo(hydromorphone HCl), CII (77605306), Dilaudid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing