Omaveloxolone is under clinical development by Reata Pharmaceuticals and currently in the Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Omaveloxolone’s likelihood of approval (LoA) and phase transition for Friedreich Ataxia took place on 30 May 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Omaveloxolone Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Omaveloxolone LOA Data

Report Segments
  • Innovator
Drug Name
  • Omaveloxolone
Administration Pathway
  • Ophthalmic
  • Oral
  • Topical
Therapeutic Areas
  • Central Nervous System
  • Musculoskeletal Disorders
  • Oncology
  • Ophthalmology
  • Toxicology
Key Developers
  • Sponsor Company: Reata Pharmaceuticals
  • Originator: Dartmouth College and University of Texas MD Anderson Cancer Center
Highest Development Stage
  • Pre-Registration

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.