Last reviewed · How we verify
Ketum
Ketum is a Small molecule drug developed by Universiti Sains Malaysia. It is currently in Phase 1 development. Also known as: Kratom.
Ketum is a substance being studied in a clinical trial for its potential to alleviate pain. The substance is also known as Ketum, but its origins and linguistic classification are unrelated to its potential medical applications, as it is derived from a Papuan language called Wambon spoken in Papua, Indonesia.
-
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 | Ketum |
|---|---|
| Also known as | Kratom |
| Sponsor | Universiti Sains Malaysia |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
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:
- Ketum CI brief — competitive landscape report
- Ketum updates RSS · CI watch RSS
- Universiti Sains Malaysia portfolio CI
Frequently asked questions about Ketum
What is Ketum?
Who makes Ketum?
Is Ketum also known as anything else?
What development phase is Ketum in?
Related
- Manufacturer: Universiti Sains Malaysia — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Kratom
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing