Metenkefalin is under clinical development by Statera Biopharma 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 Metenkefalin’s likelihood of approval (LoA) and phase transition for Pancreatic Cancer took place on 06 Jan 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Metenkefalin overview

IRT-101 (methionine-enkephalin) is under development for the treatment of pancreatic cancer, gastric cancer, colon cancer, head and neck cancer, ovarian cancer, hepatocellular carcinoma, melanoma, influenza A virus H1N1 subtype virus, HIV / AIDS, Kaposi’s sarcoma, lung cancer, hypernephroma, thyroid cancer and coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is administered through intravenous route. It acts by targeting opiod receptors. IRT-101 works by isolating a patient's lymphocytes and then incubating them together with Methionine Enkephalin (MENK) in an enriching external incubation system. After incubation the patient's lymphocytes are re-infused back into the patient where they combat and destroy tumor cells. It is being developed based on AIMS: Advanced Immunomodulating Multi-receptor System platform.

Statera Biopharma overview

Statera Biopharma is a bio-pharmaceutical company. The company develops and commercializes drugs to treat cancer, orphan indications and protect healthy tissues from radiation and chemotherapy. It product includes entolimod, a recombinant protein that acts as an agonist of toll-like receptor that finds application in radiation mitigation, oncology immunotherapy, and vaccines. Statera Biopharma provides entolimod-oncology, CBLB612, SA-702 – vaccine adjuvant, mobilan, and CBL0137. The company clinical-stage drug candidates are used for the treatment of cancer and protection from lethal radiation. It’s products includes to develop using protectan technology and curaxin technology. The company operates in the US and Russia. Statera Biopharma is headquartered in Buffalo, New York, the US.

Quick View Metenkefalin LOA Data

Report Segments
  • Innovator
Drug Name
  • Metenkefalin
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: Statera Biopharma
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.