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mitragynine
mitragynine is a Small molecule drug developed by National Institute on Drug Abuse (NIDA). It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | mitragynine |
|---|---|
| Sponsor | National Institute on Drug Abuse (NIDA) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase 1 Study of Oral MG001 (PHASE1)
- Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience (PHASE1)
- Real-world Momentary Assessment of Kratom Use Accompanied by Product Assays: A Natural-history Study for Interdisciplinary Characterization of Kratom Use and Pharmacology
- Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints (EARLY_PHASE1)
- Assessing the Pharmacokinetics and Drug Interaction Liability of Kratom, an Opioid-like Natural Product (EARLY_PHASE1)
- Ketum and Pain Tolerence (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:
- mitragynine CI brief — competitive landscape report
- mitragynine updates RSS · CI watch RSS
- National Institute on Drug Abuse (NIDA) portfolio CI
Frequently asked questions about mitragynine
What is mitragynine?
Who makes mitragynine?
What development phase is mitragynine in?
Related
- Manufacturer: National Institute on Drug Abuse (NIDA) — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing