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Velcade, Thalidomide, Dexamethasone
Velcade, Thalidomide, Dexamethasone is a Proteasome inhibitor Small molecule drug developed by University of Arkansas. It is currently in Phase 3 development for Multiple myeloma, Mantle cell lymphoma.
Velcade (bortezomib) is a proteasome inhibitor that blocks the action of proteasomes, which are complexes that break down proteins in cells.
Velcade (Bortezomib) is a small molecule used in the treatment of multiple myeloma, specifically in regimens such as the CTD (cyclophosphamide, thalidomide, and dexamethasone) and CCRD (carfilzomib, cyclophosphamide, lenalidomide, and dexamethasone) regimens. Thalidomide is also used in the treatment of multiple myeloma, often in combination with dexamethasone, as seen in the CTD regimen.
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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 | Velcade, Thalidomide, Dexamethasone |
|---|---|
| Sponsor | University of Arkansas |
| Drug class | Proteasome inhibitor |
| Target | Proteasome |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting proteasomes, Velcade disrupts the normal functioning of cells, leading to cell death, particularly in cancer cells. This mechanism is particularly effective in multiple myeloma and mantle cell lymphoma. Additionally, Thalidomide works by inhibiting the production of tumor necrosis factor-alpha (TNF-alpha), a protein that promotes inflammation and tumor growth, while Dexamethasone is a corticosteroid that suppresses the immune system and reduces inflammation.
Approved indications
- Multiple myeloma
- Mantle cell lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Diarrhea
- Nausea
- Vomiting
- Pyrexia
- Headache
- Dizziness
Key clinical trials
- UARK 2006-66, Total Therapy 3B: An Extension of UARK 2003-33 Total Therapy (PHASE3)
- Phase II Randomised Trial of Cyclophosphamide & Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma. (PHASE2)
- ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma (PHASE2)
- 2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy (PHASE2)
- Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixazomib (IXA) or IXA-Dara (PHASE2)
- Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy (PHASE2)
- UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (PHASE2)
- UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma (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:
- Velcade, Thalidomide, Dexamethasone CI brief — competitive landscape report
- Velcade, Thalidomide, Dexamethasone updates RSS · CI watch RSS
- University of Arkansas portfolio CI
Frequently asked questions about Velcade, Thalidomide, Dexamethasone
What is Velcade, Thalidomide, Dexamethasone?
How does Velcade, Thalidomide, Dexamethasone work?
What is Velcade, Thalidomide, Dexamethasone used for?
Who makes Velcade, Thalidomide, Dexamethasone?
What drug class is Velcade, Thalidomide, Dexamethasone in?
What development phase is Velcade, Thalidomide, Dexamethasone in?
What are the side effects of Velcade, Thalidomide, Dexamethasone?
What does Velcade, Thalidomide, Dexamethasone target?
Related
- Drug class: All Proteasome inhibitor drugs
- Target: All drugs targeting Proteasome
- Manufacturer: University of Arkansas — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma
- Indication: Drugs for Mantle cell lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing