Tolebrutinib is a Small Molecule owned by Principia Biopharma, and is involved in 16 clinical trials, of which 6 were completed, 8 are ongoing, and 2 are planned.

SAR-442168 (PRN-2246) acts as Bruton's tyrosine kinase (BTK) inhibitor. BCR signaling promotes cell proliferation, adhesion, and survival of cancer cells. Activation of Btk triggers the generation of calcium mobilization and transcriptional regulation and production of pro-inflammatory cytokines. The drug candidate by inhibiting BTK activity, reduces the pathogenic autoantibody production of B cells along with the pro-inflammatory cytokines resulting in immune suppression.

The revenue for Tolebrutinib is expected to reach a total of $7.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Tolebrutinib NPV Report.

Tolebrutinib is originated and owned by Principia Biopharma. Sanofi is the other company associated in development or marketing of Tolebrutinib.

Tolebrutinib Overview

SAR-442168 (PRN-2246) is under development for the treatment of  primary progressive multiple sclerosis (PPMS), relapsing remitting multiple sclerosis (RRMS), myasthenia gravis (MG) and unspecified indication. It is a small molecule administered through oral route. It acts by targeting Bruton’s tyrosine kinase (BTK) enzyme. The drug candidate is based on Tailored covalency technology platform. It was also under development for the treatment of solid tumors, secondary progressive multiple sclerosis (SPMS), generalized myasthenia gravis (MG), relapsing multiple sclerosis (RMS).

Sanofi Overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

The company reported revenues of (Euro) EUR39,175 million for the fiscal year ended December 2021 (FY2021), an increase of 4.8% over FY2020. In FY2021, the company’s operating margin was 20.7%, compared to an operating margin of 37.8% in FY2020. In FY2021, the company recorded a net margin of 15.9%, compared to a net margin of 32.9% in FY2020. The company reported revenues of EUR13,138 million for the third quarter ended September 2022, a decrease of 36.8% over the previous quarter.

Quick View – Tolebrutinib

Report Segments
  • Innovator
Drug Name
  • Tolebrutinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Immunology
  • Oncology
  • Undisclosed
Key Companies
Highest Development Stage
  • Phase III

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.