Last reviewed · How we verify
Diacetylmorphine, injectable
Diacetylmorphine, injectable is a Opioid agonist Small molecule drug developed by University of British Columbia. It is currently in Phase 3 development for Opioid use disorder (maintenance treatment in opioid-dependent patients), Severe chronic pain in opioid-tolerant patients.
Diacetylmorphine (heroin) is a mu-opioid receptor agonist that binds to opioid receptors in the central nervous system to produce analgesia and euphoria.
Diacetylmorphine (heroin) is a mu-opioid receptor agonist that binds to opioid receptors in the central nervous system to produce analgesia and euphoria. Used for Opioid use disorder (maintenance treatment in opioid-dependent patients), Severe chronic pain in opioid-tolerant patients.
-
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 | Diacetylmorphine, injectable |
|---|---|
| Sponsor | University of British Columbia |
| Drug class | Opioid agonist |
| Target | Mu-opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Pain management / Addiction medicine |
| Phase | Phase 3 |
Mechanism of action
Diacetylmorphine is a semi-synthetic opioid derived from morphine. It crosses the blood-brain barrier more readily than morphine due to its acetyl groups, allowing faster onset of action. Once in the brain, it is deacetylated to morphine and 6-monoacetylmorphine, which activate mu-opioid receptors to modulate pain perception, mood, and reward pathways.
Approved indications
- Opioid use disorder (maintenance treatment in opioid-dependent patients)
- Severe chronic pain in opioid-tolerant patients
Common side effects
- Respiratory depression
- Constipation
- Nausea and vomiting
- Sedation
- Pruritus
- Overdose risk
Key clinical trials
- Tele-Harm Reduction (NA)
- Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV
- Biomarkers of Injectable Extended Release Naltrexone Treatment (PHASE4)
- Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry (PHASE4)
- Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy (NA)
- An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
- Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension) (PHASE3)
- University of Houston Drug Abuse Research Development Program II (NA)
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:
- Diacetylmorphine, injectable CI brief — competitive landscape report
- Diacetylmorphine, injectable updates RSS · CI watch RSS
- University of British Columbia portfolio CI
Frequently asked questions about Diacetylmorphine, injectable
What is Diacetylmorphine, injectable?
How does Diacetylmorphine, injectable work?
What is Diacetylmorphine, injectable used for?
Who makes Diacetylmorphine, injectable?
What drug class is Diacetylmorphine, injectable in?
What development phase is Diacetylmorphine, injectable in?
What are the side effects of Diacetylmorphine, injectable?
What does Diacetylmorphine, injectable target?
Related
- Drug class: All Opioid agonist drugs
- Target: All drugs targeting Mu-opioid receptor (OPRM1)
- Manufacturer: University of British Columbia — full pipeline
- Therapeutic area: All drugs in Pain management / Addiction medicine
- Indication: Drugs for Opioid use disorder (maintenance treatment in opioid-dependent patients)
- Indication: Drugs for Severe chronic pain in opioid-tolerant patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing