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 $8.7bn 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.

Biogen Overview

Biogen is a biopharmaceutical company that discovers, develops, and delivers drugs and biosimilars for the treatment of various neurological and neurodegenerative diseases. The company’s marketed products include Avonex (interferon beta-1a), Tysabri (natalizumab), Tecfidera (dimethyl fumarate), Fampyra (prolonged-release fampridine tablets), and Plegridy (peginterferon beta-1a) for the treatment of multiple sclerosis (MS); Spinraza (nusinersen) for spinal muscular atrophy (SMA); and Fumaderm (fumaric acid esters) for severe plaque psoriasis. It has several product candidates targeting various indications such as MS, Parkinson’s disease, CNS and neuromuscular disorders, Alzheimer’s disease, and idiopathic pulmonary fibrosis and stroke. The company sells its products through direct sales force, marketing groups, and distributors in the Americas, Europe, Asia, and other territories. Biogen is headquartered in Cambridge, Massachusetts, the US.

The company reported revenues of (US Dollars) US$10,981.7 million for the fiscal year ended December 2021 (FY2021), a decrease of 18.3% over FY2020. In FY2021, the company’s operating margin was 25.9%, compared to an operating margin of 33.8% in FY2020. In FY2021, the company recorded a net margin of 14.2%, compared to a net margin of 29.8% in FY2020. The company reported revenues of US$2,508.5 million for the third quarter ended September 2022, a decrease of 3.1% 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.