Omaveloxolone is a Small Molecule owned by Reata Pharmaceuticals, and is involved in 14 clinical trials, of which 12 were completed, 1 is ongoing, and 1 is planned.

Omaveloxolone (RTA-408) acts as NRF2 decoy, selectively binds to KEAP1. Inhibition of KEAP1 leads to the activation of NFE2-related factor 2 (NRF2). NRF2 drives expression of a battery of genes via its interaction with the antioxidant response element (ARE). Activated NRF2 directed transcription improves redox balance, alleviates mitochondrial dysfunction, increases mitochondrial biogenesis, enhances autophagy, and reduces inflammation.

The revenue for Omaveloxolone is expected to reach a total of $5.2bn 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 Omaveloxolone NPV Report.

Omaveloxolone was originated by Dartmouth College and University of Texas MD Anderson Cancer Center and is currently owned by Reata Pharmaceuticals.

Omaveloxolone Overview

Omaveloxolone (RTA-408) is under development for the treatment of Friedreich's ataxia. The drug candidate is administered topically in the form of the lotion, orally in the form of capsule and by ophthalmic in the form of suspension. It is a member of the synthetic oleanane triterpenoid class of compounds. The drug candidate acts by targeting the mutated kelch like ECH associated protein 1 (KEAP1). The drug candidate was also under development for the treatment of corneal endothelial cell loss, radiation dermatitis, ocular inflammation and pain following ocular surgery.

It is also under development for progressive supranuclear palsy, amyotrophic lateral sclerosis, Parkinson’s disease, frontotemporal dementia, Huntington disease, Alzheimer’s disease, epilepsy, non-small cell lung cancer, mitochondrial myopathy and metastatic melanoma

Reata Pharmaceuticals Overview

Reata Pharmaceuticals (Reata) is a clinical-stage biopharmaceutical company. It develops innovative medicines for the treatment of serious and life-threatening diseases. The company’s clinical candidates include bardoxolone methyl and omaveloxolone, which target Nrf2, a transcription factor, for restoring mitochondrial function, reducing oxidative stress, and resolving inflammation. Its products also include HSP90 modulators, RTA 901, ROR?t inhibitors, and RTA 1701. Reata is evaluating bardoxolone methyl in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), alport syndrome and other kidney diseases; and omaveloxolone in Friedreich’s ataxia. The company works in partnership with academics, biotechnology, and pharmaceutical companies to develop technologies. It has operations in the US, the UK, Ireland, Australia and Switzerland. Reata is headquartered in Plano, Texas, the US.

The company reported revenues of (US Dollars) US$11.5 million for the fiscal year ended December 2021 (FY2021), an increase of 27.4% over FY2020. The operating loss of the company was US$244.7 million in FY2021, compared to an operating loss of US$236.2 million in FY2020. The net loss of the company was US$297.4 million in FY2021, compared to a net loss of US$247.8 million in FY2020. The company reported revenues of US$0.5 million for the third quarter ended September 2022, a decrease of 29.1% over the previous quarter.

Quick View – Omaveloxolone

Report Segments
  • Innovator
Drug Name
  • Omaveloxolone
Administration Pathway
  • Ophthalmic
  • Oral
  • Topical
Therapeutic Areas
  • Central Nervous System
  • Musculoskeletal Disorders
  • Oncology
  • Ophthalmology
  • Toxicology
Key Companies
Highest Development Stage
  • Pre-Registration

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.