Temozolomide is under clinical development by Orphelia Pharma and currently in Phase I for Glioblastoma Multiforme (GBM). According to GlobalData, Phase I drugs for Glioblastoma Multiforme (GBM) have an 82% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Temozolomide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Temozolomide overview

Temozolomide (ORP-005) is under development for the treatment of pediatric cancers including refractory medulloblastoma, rhabdomyosarcoma, neuroblastoma, ewing sarcoma, glioblastoma multiforme, anaplastic astrocytoma, malignant glioma and neuroblastoma. The drug candidate is administered by oral route as a suspension. It is a taste masked formulation coupled with a dispensing device to improve administration and compliance in infants and children. It acts by targeting DNA synthesis.

Orphelia Pharma overview

Orphelia Pharma is a pharmaceutical company dedicated to the development and marketing of pediatric drugs for oncology and CNS diseases. The company is headquartered in Paris, France.

For a complete picture of Temozolomide’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.