Temozolomide & Radiation Therapy

Myrexis Inc. · Phase 2 active Small molecule

Temozolomide & Radiation Therapy is a Small molecule drug developed by Myrexis Inc.. It is currently in Phase 2 development. Also known as: Temodar, TMZ, Radiotherapy.

Temozolomide is a small molecule DNA inhibitor used in the treatment of various cancers, including lung cancer, metastatic cancer, brain and central nervous system tumors, brain stem glioma, and cerebral astrocytoma. When used in conjunction with radiation therapy, temozolomide may be employed as part of a treatment regimen, although specific details on its interaction with radiation therapy are not provided in the given facts.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Temozolomide & Radiation Therapy
Also known as	Temodar, TMZ, Radiotherapy
Sponsor	Myrexis Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma (PHASE1)
• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
• 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)
• Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma (PHASE2)
• A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) (PHASE2)
• Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma (PHASE2)
• Hypofractionated Radiotherapy Plus Temozolamide in Patients Younger Than 70 Years With Glioblastoma (NA)

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:

• Temozolomide & Radiation Therapy CI brief — competitive landscape report
• Temozolomide & Radiation Therapy updates RSS · CI watch RSS
• Myrexis Inc. portfolio CI

Frequently asked questions about Temozolomide & Radiation Therapy

What is Temozolomide & Radiation Therapy?

Temozolomide & Radiation Therapy is a Small molecule drug developed by Myrexis Inc..

Who makes Temozolomide & Radiation Therapy?

Temozolomide & Radiation Therapy is developed by Myrexis Inc. (see full Myrexis Inc. pipeline at /company/myrexis-inc).

Is Temozolomide & Radiation Therapy also known as anything else?

Temozolomide & Radiation Therapy is also known as Temodar, TMZ, Radiotherapy.

What development phase is Temozolomide & Radiation Therapy in?

Temozolomide & Radiation Therapy is in Phase 2.

Related

• Manufacturer: Myrexis Inc. — full pipeline
• Also known as: Temodar, TMZ, Radiotherapy