RUTI is under clinical development by Archivel Farma 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 RUTI’s likelihood of approval (LoA) and phase transition for Tuberculosis took place on 06 Jul 2022, 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 RUTI Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

RUTI overview

RUTI is under development for the treatment of latent tuberculosis (TB), multi-drug resistant tuberculosis (MDR-TB) and non-muscle-invasive bladder cancer (NMIBC) Coronavirus Disease 2019 (COVID-19). The drug candidate is administered subcutaneously. RUTI is a lyophilized, new polyantigenic vaccine. It is produced from Mycobacterium tuberculosis fragmented into tiny particles and detoxified in order to eliminate the toxic substances produced by the bacillus. It was also under development for the treatment of non-muscle-invasive bladder cancer (NMIBC).

Archivel Farma overview

Archivel Farma is a biopharmaceutical company that develops drugs. The company’s activities comprise research and clinical development of drugs in the field of tuberculosis, primarily for the latent tuberculosis infection. It in cooperation with the Research Institute for Health Sciences and Germans Triasi Pujol University Hospital Germans Triasi Pujol developed RUTI, a poly antigenic vaccine for the prophylactic use and to treat Latent tuberculosis infection LTBI. Archivel Farma develops biopharmaceutical agents for preventing and treating other diseases susceptible to immunomodulatory interventions. The company develops sterile biological drugs through its manufacturing facilities located in Bardalona. Archivel Farma is headquartered in Badalona, Spain.

Quick View RUTI LOA Data

Report Segments
  • Innovator
Drug Name
  • RUTI
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: Archivel Farma
  • Originator: Fundacio Institut d’Investigacio en Ciencies de la Salut Germans Trias i Pujol
Highest Development Stage
  • Phase III

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.