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Kratom
Kratom is a Small molecule drug developed by Altasciences Company Inc.. 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 | Kratom |
|---|---|
| Sponsor | Altasciences Company Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults (NA)
- Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use (PHASE1)
- Direct Observation Study of Kratom Product Effects Among Regular Consumers
- Preliminary Characterization of Commercial Kratom Extract Products
- 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
- Kratom Use Disorder Management Using Clonidine and/or Buprenorphine
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:
- Kratom CI brief — competitive landscape report
- Kratom updates RSS · CI watch RSS
- Altasciences Company Inc. portfolio CI
Frequently asked questions about Kratom
What is Kratom?
Who makes Kratom?
What development phase is Kratom in?
Related
- Manufacturer: Altasciences Company Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing