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TLK286 HCl for injection
TLK286 HCl for injection is a Proteasome inhibitor Small molecule drug developed by Telik. It is currently in Phase 3 development for Multiple myeloma.
TLK286 HCl for injection is a proteasome inhibitor.
TLK286 HCl for injection is a medication used to treat various types of cancer, including ovarian neoplasms, mantle cell lymphoma, B cell lymphoma, multiple myeloma, and non small cell lung carcinoma. The exact mechanism of action of TLK286 HCl is unknown.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | TLK286 HCl for injection |
|---|---|
| Sponsor | Telik |
| Drug class | Proteasome inhibitor |
| Target | 20S proteasome |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
It works by inhibiting the 20S proteasome, a protein complex involved in protein degradation. This leads to an accumulation of defective proteins, which can trigger cell death in cancer cells.
Approved indications
- Multiple myeloma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Nausea
Key clinical trials
- Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma (PHASE2)
- TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer (PHASE3)
- Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (PHASE3)
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:
- TLK286 HCl for injection CI brief — competitive landscape report
- TLK286 HCl for injection updates RSS · CI watch RSS
- Telik portfolio CI
Frequently asked questions about TLK286 HCl for injection
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Related
- Drug class: All Proteasome inhibitor drugs
- Target: All drugs targeting 20S proteasome
- Manufacturer: Telik — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing