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Thalidomide/Prednisone/Velcade
Thalidomide/Prednisone/Velcade is a Anti-angiogenic agent, Corticosteroid, Proteasome inhibitor Small molecule drug developed by PETHEMA Foundation. It is currently in Phase 3 development for Multiple myeloma, Erythema nodosum leprosum.
Thalidomide inhibits angiogenesis and immunomodulation, while Prednisone is a corticosteroid with anti-inflammatory effects, and Velcade (Bortezomib) is a proteasome inhibitor.
Velcade (Bortezomib) is a small molecule used in the treatment of multiple myeloma, often in combination with other medications such as Dexamethasone and Melphalan. In clinical trials, Velcade has been studied alongside Thalidomide and Prednisone, as well as other regimens, to evaluate its effectiveness in treating previously untreated multiple myeloma patients.
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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 | Thalidomide/Prednisone/Velcade |
|---|---|
| Sponsor | PETHEMA Foundation |
| Drug class | Anti-angiogenic agent, Corticosteroid, Proteasome inhibitor |
| Target | None specified |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Thalidomide's antiangiogenic properties are thought to be responsible for its therapeutic effects. Prednisone's anti-inflammatory effects are mediated through its ability to suppress the immune system. Velcade's mechanism of action involves the inhibition of the 26S proteasome, leading to the accumulation of defective proteins and the induction of apoptosis in cancer cells.
Approved indications
- Multiple myeloma
- Erythema nodosum leprosum
Common side effects
- Neuropathy
- Fatigue
- Diarrhea
- Thrombocytopenia
- Anemia
Key clinical trials
- A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma (PHASE1)
- Velcade, Melphalan, Prednisone And Thalidomide Versus Velcade, Melphalan, Prednisone in Multiple Myeloma Patients (PHASE3)
- Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone (PHASE3)
- Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma (PHASE4)
- GEM05 for Patients With Multiple Myeloma More Than 65 Years Old (PHASE3)
- GEM05 for Patients With Multiple Myeloma Under 65 Years (PHASE3)
- VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates (PHASE2)
- Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients (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:
- Thalidomide/Prednisone/Velcade CI brief — competitive landscape report
- Thalidomide/Prednisone/Velcade updates RSS · CI watch RSS
- PETHEMA Foundation portfolio CI
Frequently asked questions about Thalidomide/Prednisone/Velcade
What is Thalidomide/Prednisone/Velcade?
How does Thalidomide/Prednisone/Velcade work?
What is Thalidomide/Prednisone/Velcade used for?
Who makes Thalidomide/Prednisone/Velcade?
What drug class is Thalidomide/Prednisone/Velcade in?
What development phase is Thalidomide/Prednisone/Velcade in?
What are the side effects of Thalidomide/Prednisone/Velcade?
What does Thalidomide/Prednisone/Velcade target?
Related
- Drug class: All Anti-angiogenic agent, Corticosteroid, Proteasome inhibitor drugs
- Target: All drugs targeting None specified
- Manufacturer: PETHEMA Foundation — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma
- Indication: Drugs for Erythema nodosum leprosum
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing