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Heroin
Heroin is a Small molecule drug developed by MetroHealth Medical Center. It is currently in Phase 3 development for Severe pain. Also known as: Diacetylmorphine.
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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 | Heroin |
|---|---|
| Also known as | Diacetylmorphine |
| Sponsor | MetroHealth Medical Center |
| Target | D(1A) dopamine receptor, D(2) dopamine receptor, D(3) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Approved indications
- Severe pain
Common side effects
Key clinical trials
- Developing Field Tools for Real-Time Assessment of Exposure to Psychosocial Stress and Drug Use in an Outpatient Treatment Population
- Tele-Harm Reduction (NA)
- Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction (NA)
- Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD (NA)
- Suvorexant for Opioid/Stimulant Co-use (PHASE2)
- Motivational Interviewing to Increase Uptake of Drug Checking and Safe Drug Use Behaviors to Reduce Overdose (NA)
- Neuroimaging and CBD for Opioid Use Disorder (PHASE2)
- Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose (PHASE2, PHASE3)
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:
- Heroin CI brief — competitive landscape report
- Heroin updates RSS · CI watch RSS
- MetroHealth Medical Center portfolio CI
Frequently asked questions about Heroin
What is Heroin?
What is Heroin used for?
Who makes Heroin?
Is Heroin also known as anything else?
What development phase is Heroin in?
What does Heroin target?
Related
- Target: All drugs targeting D(1A) dopamine receptor, D(2) dopamine receptor, D(3) dopamine receptor
- Manufacturer: MetroHealth Medical Center — full pipeline
- Therapeutic area: All drugs in Pain
- Indication: Drugs for Severe pain
- Also known as: Diacetylmorphine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing