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DCL-101 vs Golytely
DCL-101 vs Golytely is a KRAS G12C inhibitor Small molecule drug developed by Dark Canyon Laboratories, LLC. It is currently in Phase 2 development for Non-small cell lung cancer with KRAS G12C mutation.
DCL-101 is a small molecule that targets the KRAS G12C mutation, inhibiting the KRAS protein's ability to promote cancer cell growth.
DCL-101 is a small molecule that targets the KRAS G12C mutation, inhibiting the KRAS protein's ability to promote cancer cell growth. Used for Non-small cell lung cancer with KRAS G12C mutation.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | DCL-101 vs Golytely |
|---|---|
| Sponsor | Dark Canyon Laboratories, LLC |
| Drug class | KRAS G12C inhibitor |
| Target | KRAS G12C |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
DCL-101 works by selectively binding to the KRAS G12C mutation, preventing the protein from interacting with downstream effectors and thereby inhibiting the MAPK signaling pathway. This leads to a decrease in cancer cell proliferation and an increase in apoptosis. The KRAS G12C mutation is a common driver mutation in non-small cell lung cancer and other solid tumors.
Approved indications
- Non-small cell lung cancer with KRAS G12C mutation
Common side effects
- Diarrhea
- Fatigue
- Nausea
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:
- DCL-101 vs Golytely CI brief — competitive landscape report
- DCL-101 vs Golytely updates RSS · CI watch RSS
- Dark Canyon Laboratories, LLC portfolio CI
Frequently asked questions about DCL-101 vs Golytely
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Related
- Drug class: All KRAS G12C inhibitor drugs
- Target: All drugs targeting KRAS G12C
- Manufacturer: Dark Canyon Laboratories, LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer with KRAS G12C mutation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing