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Diamorphine hydrochloride
Diamorphine hydrochloride is a Opioid agonist Small molecule drug developed by University of British Columbia. It is currently in Phase 3 development for Severe pain management, Opioid substitution therapy / opioid use disorder.
Diamorphine hydrochloride is an opioid agonist that binds to mu, delta, and kappa opioid receptors in the central and peripheral nervous system to produce analgesia and euphoria.
Diamorphine hydrochloride, also known as heroin, is used in clinical trials to study conditions such as substance-related disorders, HIV risk behavior, and terminal cancer. It is often compared to other interventions like methadone and buprenorphine in these trials.
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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 | Diamorphine hydrochloride |
|---|---|
| Sponsor | University of British Columbia |
| Drug class | Opioid agonist |
| Target | Mu opioid receptor (primary), delta opioid receptor, kappa opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Addiction Medicine |
| Phase | Phase 3 |
Mechanism of action
Diamorphine (heroin) is a semi-synthetic opioid derived from morphine that crosses the blood-brain barrier more readily than morphine due to its lipophilicity. Once in the brain, it is rapidly deacetylated to morphine and 6-monoacetylmorphine, which activate opioid receptors to modulate pain perception, emotional response, and reward pathways. It is used clinically for severe pain management and opioid substitution therapy.
Approved indications
- Severe pain management
- Opioid substitution therapy / opioid use disorder
Common side effects
- Respiratory depression
- Constipation
- Nausea and vomiting
- Sedation
- Dependence and withdrawal
- Overdose risk
Key clinical trials
- Acupuncture for Prevention of Itch in Caesarean Section (NA)
- Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy (NA)
- Re-Treatment Study of Probuphine in Opioid Addiction (PHASE3)
- A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence (PHASE3)
- A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction (PHASE3)
- Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence (PHASE3)
- Study of Probuphine in Patients With Opioid Dependence (PHASE3)
- Nasal Fentanyl and Buccal Midazolam for Dying 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:
- Diamorphine hydrochloride CI brief — competitive landscape report
- Diamorphine hydrochloride updates RSS · CI watch RSS
- University of British Columbia portfolio CI
Frequently asked questions about Diamorphine hydrochloride
What is Diamorphine hydrochloride?
How does Diamorphine hydrochloride work?
What is Diamorphine hydrochloride used for?
Who makes Diamorphine hydrochloride?
What drug class is Diamorphine hydrochloride in?
What development phase is Diamorphine hydrochloride in?
What are the side effects of Diamorphine hydrochloride?
What does Diamorphine hydrochloride target?
Related
- Drug class: All Opioid agonist drugs
- Target: All drugs targeting Mu opioid receptor (primary), delta opioid receptor, kappa opioid receptor
- Manufacturer: University of British Columbia — full pipeline
- Therapeutic area: All drugs in Pain Management, Addiction Medicine
- Indication: Drugs for Severe pain management
- Indication: Drugs for Opioid substitution therapy / opioid use disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing