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Temodal
Temodal is a Small molecule drug developed by Armando Santoro, MD. It is currently in Phase 1 development for Astrocytoma, anaplastic, Ewing's sarcoma, Glioblastoma multiforme of brain. Also known as: Temozolomide.
Temozolomide, also known as Temodar, is an anticancer medication used to treat various types of brain tumors, including glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma. It is a small molecule DNA inhibitor that can be taken by mouth or via intravenous infusion.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Temodal |
|---|---|
| Also known as | Temozolomide |
| Sponsor | Armando Santoro, MD |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 1 |
Approved indications
- Astrocytoma, anaplastic
- Ewing's sarcoma
- Glioblastoma multiforme of brain
- Glioma, malignant
Common side effects
Key clinical trials
- Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas (PHASE1)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment (PHASE1, PHASE2)
- Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (PHASE2, PHASE3)
- Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness (PHASE1, PHASE2)
- Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations (PHASE2)
- Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma (PHASE1)
- Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer (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:
- Temodal CI brief — competitive landscape report
- Temodal updates RSS · CI watch RSS
- Armando Santoro, MD portfolio CI
Frequently asked questions about Temodal
What is Temodal?
What is Temodal used for?
Who makes Temodal?
Is Temodal also known as anything else?
What development phase is Temodal in?
Related
- Manufacturer: Armando Santoro, MD — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Astrocytoma, anaplastic
- Indication: Drugs for Ewing's sarcoma
- Indication: Drugs for Glioblastoma multiforme of brain
- Also known as: Temozolomide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing