Omaveloxolone (RTA-408) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 597

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 have evaluated omaveloxolone for neuromuscular and neurodegenerative disorders such as Friedreich ataxia and mitochondrial myopathies, oncology indications like non-small cell lung cancer and refractory melanoma, and ophthalmic and hepatic conditions. Sponsored by academic institutions and biopharmaceutical companies including Biogen and Reata Pharmaceuticals, these studies assess safety, tolerability, pharmacokinetics, and clinical outcomes across completed, actively recruiting, and not yet recruiting stages.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06054893	ACTIVE_NOT_RECRUITING	Friedreich Ataxia	Biogen	2024-07-01	PHASE1
NCT06953583	RECRUITING	Friedreich Ataxia	Biogen	2025-06-09	PHASE3
NCT07297199	COMPLETED	Healthy Volunteer	Biogen	2025-12-12	PHASE1
NCT07149415	COMPLETED	Healthy Volunteer	Biogen	2025-09-02	PHASE1
NCT07019064	COMPLETED	Healthy Volunteer	Biogen	2025-06-11	PHASE1
NCT06612879	COMPLETED	Healthy Volunteer	Biogen	2024-10-18	PHASE1
NCT06054893	Not yet recruiting	Friedreich Ataxia	Biogen	2023-11-01	Phase 1
NCT05927649	COMPLETED	Health Adult Subjects	Biogen	2023-07-11	PHASE1
NCT05909644	COMPLETED	Healthy Adult Subjects	Biogen	2023-07-05	PHASE1
NCT05909644	Completed	Healthy Adult Subjects	Reata a wholly owned subsidiary of Biogen\|Celerion\|Q2 Solutions\|Altasciences Company Inc.\|Biogen	2023-07-05	Phase 1
NCT03902002	COMPLETED	Hepatic Impairment	Biogen	2019-07-19	PHASE1
NCT02255435	COMPLETED	Friedreich Ataxia	Biogen	2015-01-31	PHASE2
NCT04008186	COMPLETED	Healthy Adult Subjects	Biogen	2019-06-14	PHASE1
NCT03902002	Completed	Hepatic Impairment	Reata a wholly owned subsidiary of Biogen\|Biogen	2019-07-19	Phase 1
NCT03931590	COMPLETED	Healthy Male Subjects	Biogen	2019-04-11	PHASE1
NCT03931590	Completed	Healthy Male Subjects	Reata a wholly owned subsidiary of Biogen\|Biogen	2019-04-11	Phase 1
NCT03664453	COMPLETED	Healthy	Biogen	2018-10-29	PHASE1
NCT03664453	Completed	Healthy	Reata a wholly owned subsidiary of Biogen\|Biogen	2018-10-29	Phase 1
NCT02259231	COMPLETED	Melanoma; Unresectable (Stage III) Melanoma; Metastatic (Stage IV) Melanoma	Biogen	2014-10-31	PHASE1; PHASE2
NCT02255422	COMPLETED	MItochondrial Myopathies	Biogen	2015-05-05	PHASE2
NCT02029729	COMPLETED	Metastatic or Incurable Non-small Cell Lung Cancer; Relapsed, Refractory Melanoma	Biogen	2013-12-31	PHASE1
NCT02142959	COMPLETED	Breast Cancer	Biogen	2014-06-30	PHASE2
NCT02128113	COMPLETED	Corneal Endothelial Cell Loss; Ocular Pain; Ocular Inflammation; Cataract Surgery	Biogen	2014-05-31	PHASE2
NCT02065375	COMPLETED	Inflammation and Pain Following Ocular Surgery	Biogen	2014-02-28	PHASE2
NCT02029716	COMPLETED	Healthy	Biogen	2013-12-31	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Omaveloxolone (RTA-408) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Omaveloxolone (RTA-408) is a synthetic triterpenoid that binds to Keap1 to promote the nuclear translocation of Nrf2 while simultaneously suppressing nuclear factor kappa B (NF-κB) transcription, thereby upregulating antioxidant genes and attenuating pro-inflammatory mediator production. This restoration of cellular redox homeostasis and mitochondrial function mitigates oxidative damage, providing therapeutic rationale for its evaluation in neurodegenerative conditions such as Friedreich Ataxia and inflammatory or malignant disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).