Brexanolone is a Small Molecule owned by Sage Therapeutics, and is involved in 20 clinical trials, of which 13 were completed, 4 are ongoing, and 3 are planned.

SAGE-547 is a positive gamma-aminobutyric acid type A receptor allosteric modulator. GABA helps in maintaining appropriate electrical activity. The drug candidate may potentiate gamma-aminobutyric acid-mediated chloride current influx that leads to hyperpolarization of the neuron which may lead to down-regulation of excitation. The drug candidate positively modulates the GABAA receptor and proves to be effective in the treatment the condition by checking the underlying cause of disease progression.

The revenue for Brexanolone is expected to reach a total of $232m 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 Brexanolone NPV Report.

Brexanolone was originated by University of California and is currently owned by Sage Therapeutics.

Brexanolone Overview

Brexanolone (Zulresso) is a  mixture of allopregnanolone and sulfobutylether-beta-cyclodextrin, acts as an anti-depressant. It is formulated as injectable solution for intravenous route of administration. Zulresso is indicated for the treatment of postpartum depression (PPD) in adults. Zulresso is indicated for the treatment of postpartum depression in patients 15 years of age and older.

SAGE-547 (SGE-120) is under development for the treatment of severe postpartum depression (PPD), Post-traumatic stress disorder (PTSD), psychosis, tinnitus and alcohol addiction. The drug candidate is administered through intravenous injection. The drug candidate is a formulation of allopregnanolone, a metabolite of progesterone formed in the CNS. It is a positive GABAA receptor allosteric modulator. The drug candidate is based on positive and negative allosteric modulator (PANAM) chemistry platform. The PANAM technology comprises of non-benzodiazepine approach that regulates allosteric modulation of GABAA receptor in the positive (PAM) direction. It was also under development for the treatment of super-refractory status epilepticus (SE), traumatic brain injury, major depressive disorder, Alzheimer's disease, mild cognitive impairment, COVID-19 related acute respiratory distress syndrome (ARDS) and essential tremor.

Sage Therapeutics Overview

Sage Therapeutics (Sage) is a clinical-stage biopharmaceutical company that discovers, develops and markets drugs for the treatment of central nervous system (CNS) disorders. It develops drugs based on selective allosteric modulation of CNS synaptic and extrasynaptic receptors of NMDA and GABA. Its flagship product Zulresso (brexanolone) is a proprietary intravenous (IV) formulation administered for the treatment of postpartum depression (PPD). The company also has various pipeline products for the treatment of indications such as major depressive disorders, bipolar depression, Parkinson’s disease, insomnia, epileptiform disorders and NMDA hypofunction. The company operates in the US, Bermuda, Germany, Switzerland, England, and Wales through its subsidiaries. Sage is headquartered in Cambridge, Massachusetts, the US.

The company reported revenues of (US Dollars) US$6.3 million for the fiscal year ended December 2021 (FY2021), a decrease of 99.4% over FY2020. The operating loss of the company was US$460.9 million in FY2021, compared to an operating profit of US$596.2 million in FY2020. The net loss of the company was US$457.9 million in FY2021, compared to a net profit of US$606.1 million in FY2020. The company reported revenues of US$1.7 million for the third quarter ended September 2022, an increase of 15.9% over the previous quarter.

Quick View – Brexanolone

Report Segments
  • Innovator (NME)
Drug Name
  • Brexanolone
Administration Pathway
  • Intramuscular
  • Intravenous
Therapeutic Areas
  • Central Nervous System
  • Ear Nose Throat Disorders
  • Infectious Disease
  • Women’s Health
Key Companies
Highest Development Stage
  • Marketed

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.