Ulotaront hydrochloride is a Small Molecule owned by Sunovion Pharmaceuticals, and is involved in 26 clinical trials, of which 12 were completed, 11 are ongoing, and 3 are planned.

Ulotaront hydrochloride (SEP-363856) acts by agonizing TAAR1 and 5-HT1A receptors. The negative symptoms and cognitive impairment are caused by a deficit in dopaminergic neurotransmission in the mesocortical brain pathway. The trace amine-associated receptor 1 (TAAR1) is a G-protein-coupled receptor bound by endogenous trace amines and plays a role in regulation of dopaminergic, serotonergic and glutamatergic activity. 5-HT1A receptor density in the prefrontal cortex is increased in schizophrenia. The drug candidate by agonizing TAAR1 reduces multiple behavioral effects of drugs of abuse through their actions on the mesocorticolimbic system  and checks the progression of disease.

The revenue for Ulotaront hydrochloride is expected to reach a total of $4.9bn 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 Ulotaront hydrochloride NPV Report.

Ulotaront hydrochloride is originated and owned by Sunovion Pharmaceuticals. Sumitomo Pharma is the other company associated in development or marketing of Ulotaront hydrochloride.

Ulotaront hydrochloride Overview

Ulotaront hydrochloride (SEP-363856, SEP-856) is under development for the treatment of narcolepsy-cataplexy, schizophrenia, major depressive disorder, generalized anxiety disorder (GAD) and Parkinson’s disease psychosis. The drug candidate is administered orally. It is an anti-psychotic agent. It acts by targeting TAAR1 and serotonin 5-HT1A receptors. It is developed based on the PsychoGenics artificial intelligence (AI) technology.

Sumitomo Pharma Overview

Sumitomo Pharma, a subsidiary of Sumitomo Chemical Co Ltd develops, manufactures, sells, imports and exports pharmaceutical products. The company drugs are focused on major therapeutic areas which include regenerative diseases, oncology, psychiatry and neurology and infectious diseases. It also offers veterinary medicines for companion animals, primarily dogs, and cats, as well as for livestock such as cattle, swine, poultry, horses, and aquacultured fish. It also offers food additives, chemical product materials, food ingredients, and other products. Sumitomo Dainippon has research laboratories and manufacturing and distribution facilities in Japan. The company operates through subsidiaries and offices in North America, Europe, and Asia Pacific. Sumitomo Pharma is headquartered in Osaka, Japan.

The company reported revenues of (Yen) JPY560,035 million for the fiscal year ended March 2022 (FY2022), an increase of 8.5% over FY2021. In FY2022, the company’s operating margin was 10.8%, compared to an operating margin of 13.8% in FY2021. In FY2022, the company recorded a net margin of 10.1%, compared to a net margin of 10.9% in FY2021. The company reported revenues of JPY159,413 million for the second quarter ended September 2022, a decrease of 0.3% over the previous quarter.

Quick View – Ulotaront hydrochloride

Report Segments
  • Innovator
Drug Name
  • Ulotaront hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
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.