7 completed, 1 terminated, 1 withdrawn. 5 Phase 2, 4 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 4, Withdrawn 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 3 | 1 | Terminated 1 |
Follow ORF 50 transactivator: new trials by email Literature Review of ORF 50 transactivator trials Research Report on ORF 50 transactivator
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and PK/PD of RTA 1701 in Healthy Adults Placebo oral capsule, RTA 1701 capsules - Healthy | Phase 1 | Completed | Biogen | 90 | 2018-06-20 | 2025-05-29 |
| A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults RTA 901 Capsules, 10 or 40 mg, Placebo - Healthy | Phase 1 | Completed | Biogen | 78 | 2017-01-01 | 2025-05-29 |
| Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST Placebo capsules, Bardoxolone methyl capsules - Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Phase 3 | Terminated | Biogen | 202 | 2016-10-04 | 2025-06-04 |
| RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg - MItochondrial Myopathies | Phase 2 | Completed | Biogen | 53 | 2015-05-05 | 2025-06-05 |
| A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg - Friedreich Ataxia | Phase 2 | Completed | Biogen | 172 | 2015-01-31 | 2026-09-03 |
| RTA 408 Capsules in Patients With Melanoma - REVEAL Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg) - Melanoma, Unresectable (Stage III) Melanoma | Phase 1 / Phase 2 | Completed | Biogen | 41 | 2014-10-31 | 2025-06-04 |
| Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT Bardoxolone methyl, Placebo - Pulmonary Arterial Hypertension, Pulmonary Hypertension | Phase 2 | Completed | Biogen | 166 | 2014-05-31 | 2025-06-10 |
| RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER omaveloxolone - Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma | Phase 1 | Completed | Biogen | 11 | 2013-12-31 | 2025-05-29 |
| Study of Two Dose Levels of RTA 402 in Patients With Advanced Malignant Melanoma RTA 402 Dose1, RTA 402 Dose2 - Malignant Melanoma | Phase 2 | Withdrawn | Biogen | 2025-05-31 |
Melanoma (3) · Hypertension, Pulmonary (2) · Neoplasm Metastasis (2) · Pulmonary Arterial Hypertension (2) · Carcinoma, Non-Small-Cell Lung (1) · Cryptogenic Organizing Pneumonia (1) · Friedreich Ataxia (1) · Hamman-Rich Syndrome (1) · Idiopathic Interstitial Pneumonias (1) · Idiopathic Pulmonary Fibrosis (1) · Interstitial Pneumonitis, Desquamative, Familial (1) · Lung Diseases, Interstitial (1) · Mitochondrial Diseases (1) · Mitochondrial Myopathies (1) · Recurrence (1)
Biogen (9)
United States (7) · Australia (3) · Germany (2) · United Kingdom (2) · Argentina (1) · Austria (1) · Belgium (1) · Brazil (1) · Canada (1) · Czechia (1) · Denmark (1) · Israel (1) · Italy (1) · Japan (1) · Mexico (1)