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Thalidomide, Cyclophosphamide, Dexamethasone
Thalidomide, Cyclophosphamide, Dexamethasone is a Glutamic acid derivative, Alkylating agent, Corticosteroid Small molecule drug developed by Grupo de Estudos Multicentricos em Onco-Hematologia. It is currently in Phase 3 development for Multiple myeloma, Mantle cell lymphoma.
Thalidomide is a glutamic acid derivative that inhibits tumor necrosis factor-alpha (TNF-alpha) production, while Cyclophosphamide is an alkylating agent that interferes with DNA replication, and Dexamethasone is a corticosteroid that suppresses inflammation and immune response.
Thalidomide, Cyclophosphamide, and Dexamethasone are small molecule drugs used in the treatment of Multiple Myeloma.
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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, Cyclophosphamide, Dexamethasone |
|---|---|
| Sponsor | Grupo de Estudos Multicentricos em Onco-Hematologia |
| Drug class | Glutamic acid derivative, Alkylating agent, Corticosteroid |
| Target | TNF-alpha, DNA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Thalidomide's mechanism of action involves the inhibition of TNF-alpha production, which is a pro-inflammatory cytokine involved in the pathogenesis of multiple myeloma. Cyclophosphamide works by cross-linking DNA strands, thereby interfering with DNA replication and leading to cell death. Dexamethasone, on the other hand, exerts its effects by suppressing inflammation and immune response, which is beneficial in reducing the symptoms associated with multiple myeloma.
Approved indications
- Multiple myeloma
- Mantle cell lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Nausea
Key clinical trials
- The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM (PHASE4)
- EDOCH Alternating With DHAP for New Diagnosed Younger MCL (PHASE4)
- 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)
- 2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy (PHASE2)
- Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis (PHASE3)
- 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)
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, Cyclophosphamide, Dexamethasone CI brief — competitive landscape report
- Thalidomide, Cyclophosphamide, Dexamethasone updates RSS · CI watch RSS
- Grupo de Estudos Multicentricos em Onco-Hematologia portfolio CI
Frequently asked questions about Thalidomide, Cyclophosphamide, Dexamethasone
What is Thalidomide, Cyclophosphamide, Dexamethasone?
How does Thalidomide, Cyclophosphamide, Dexamethasone work?
What is Thalidomide, Cyclophosphamide, Dexamethasone used for?
Who makes Thalidomide, Cyclophosphamide, Dexamethasone?
What drug class is Thalidomide, Cyclophosphamide, Dexamethasone in?
What development phase is Thalidomide, Cyclophosphamide, Dexamethasone in?
What are the side effects of Thalidomide, Cyclophosphamide, Dexamethasone?
What does Thalidomide, Cyclophosphamide, Dexamethasone target?
Related
- Drug class: All Glutamic acid derivative, Alkylating agent, Corticosteroid drugs
- Target: All drugs targeting TNF-alpha, DNA
- Manufacturer: Grupo de Estudos Multicentricos em Onco-Hematologia — 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