GX-301 is under clinical development by Mediolanum farmaceutici and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect GX-301’s likelihood of approval (LoA) and phase transition for Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer took place on 17 Dec 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their GX-301 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

GX-301 overview

GX-301 is under development for the treatment of castration-resistant prostate cancer. It is administered through intradermal route as a solution. GX-301 is a vaccine acts by targeting telomerase. The vaccine candidate is based on four peptides which are derived from human telomerase reverse transcriptase (hTERT) and two complementary adjuvants, Montanide ISA-51 VG and imiquimod. It was also under the development for kidney cancer (renal cell cancer).

Mediolanum farmaceutici overview

Mediolanum farmaceutici (Mediolanum) is a developer and supplier of pharmaceuticals products and prescription drugs. The company offers products in therapeutic areas, which include neuropsychiatric, osteoarticular, antibiotic, pneumoallergological, vascular area and cardiometabolics. It offers products for neuropsychiatric area, which include anxiety, depression and migraine. Mediolanum provides products for vascular area which include peripheral obliterant arteriopathy and chronic venous insufficiency. The company invests in various patents and projects in areas of endocrinology, rheumatoid arthritis, vaccines for prostate and kidney cancer, and others. Mediolanum is headquartered in Milan, Italy.

Quick View GX-301 LOA Data

Report Segments
  • Innovator
Drug Name
  • GX-301
Administration Pathway
  • Intradermal
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Mediolanum farmaceutici
  • Originator: Genovax
Highest Development Stage
  • Phase II


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.