Last reviewed · How we verify
BEBT-109 Capsules
BEBT-109 Capsules is a Small molecule drug developed by BeBetter Med Inc. It is currently in Phase 2 development. Also known as: KCBT-1083.
BEBT-109 Capsules are a small molecule being studied in a clinical trial for the treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutation. The capsules are being evaluated in a multicenter Phase II study in combination with Pemetrexed Disodium for Injection.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | BEBT-109 Capsules |
|---|---|
| Also known as | KCBT-1083 |
| Sponsor | BeBetter Med Inc |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer (PHASE2)
- Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations (PHASE2)
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:
- BEBT-109 Capsules CI brief — competitive landscape report
- BEBT-109 Capsules updates RSS · CI watch RSS
- BeBetter Med Inc portfolio CI
Frequently asked questions about BEBT-109 Capsules
What is BEBT-109 Capsules?
Who makes BEBT-109 Capsules?
Is BEBT-109 Capsules also known as anything else?
What development phase is BEBT-109 Capsules in?
Related
- Manufacturer: BeBetter Med Inc — full pipeline
- Also known as: KCBT-1083
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing