Zuranolone is a Small Molecule owned by Sage Therapeutics, and is involved in 21 clinical trials, of which 14 were completed, 6 are ongoing, and 1 is planned.

Zuranolone (SAGE-217) acts as GABAA receptor allosteric modulator. GABA helps in maintaining appropriate electrical activity. The drug candidate is coupled to gamma-aminobutyric acid-A (GABAA) receptors and enhances the effects of GABA by increasing GABA affinity for the GABAA receptor. Binding of GABA to the site opens the chloride channel, resulting in a hyper polarized cell membrane that prevents further excitation of the cell. The ability to up-regulate and down-regulate GABA-A with high selectivity helps in the treatment of the disease with high specificity.

The revenue for Zuranolone is expected to reach a total of $1.7bn 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 Zuranolone NPV Report.

Zuranolone is originated and owned by Sage Therapeutics. Biogen and Shionogi & are the other companies associated in development or marketing of Zuranolone.

Zuranolone Overview

Zuranolone (SAGE-217, SAGE-NCE) is under development for the treatment of postpartum depression, bipolar disorder, major depressive disorder and generalized anxiety disorder. It is administered by the oral route. It is a new chemical entity (NCE) that targets GABAA receptor. SAGE-NCE is developed based on positive and negative allosteric modulator (PANAM) chemistry platform. It was also under development as an intravenous therapy for refractory status epilepticus (RSE) and as an oral therapy for orphan genetic epilepsy disorders, such as Dravet syndrome, Rett syndrome and Fragile X syndromes. The drug candidate was also under development for essential tremors, dyskinesias, insomnia and Parkinson’s disease.

Shionogi & Overview

Shionogi & (Shionogi) focuses on the research, development, manufacturing, and marketing of pharmaceutical products, diagnostic reagents, and medical devices. It develops innovative products and services in collaboration with its partners. The company offers prescription drugs, over-the-counter (OTC) drugs, and diagnostic products for the therapeutic areas including metabolic disorders, infectious diseases, pain/central nervous system (CNS), and cancer. It offers contract development and manufacturing facilities including all stages from drug development to commercial manufacturing. The company operates a network of subsidiaries, branches, sales offices manufacturing plants, and research laboratories across Japan, China, Taiwan; North America and Europe. Shionogi is headquartered in Osaka, Japan.

The company reported revenues of (Yen) JPY335,138 million for the fiscal year ended March 2022 (FY2022), an increase of 12.8% over FY2021. In FY2022, the company’s operating margin was 32.9%, compared to an operating margin of 39.5% in FY2021. In FY2022, the company recorded a net margin of 34.1%, compared to a net margin of 37.6% in FY2021. The company reported revenues of JPY78,939 million for the second quarter ended September 2022, an increase of 9.9% over the previous quarter.

Quick View – Zuranolone

Report Segments
  • Innovator
Drug Name
  • Zuranolone
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Women’s Health
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.