In this study, researchers will learn how BIIB141, also known as omaveloxolone or SKYCLARYS®, moves through the body. This is a drug available for doctors to prescribe for patients with Friedrich's Ataxia. But, this drug has not yet been tested in women who have recently given birth and are breastfeeding or pumping milk for their babies. So, researchers do not know how much of the drug could be passed on to babies through the breastmilk of mothers who may take BIIB141.
The main objective of this study is to learn how a single dose of BIIB141 is processed in both the breastmilk and in the blood of healthy women who are breastfeeding.
The main question researchers want to answer in this study is:
* How does BIIB141 move from the blood into the breastmilk?
Researchers will also learn more about:
* How BIIB141 moves through the blood
* What dose of BIIB141 a baby may get from the mother's breastmilk
* Any medical problems the participants have during the study
This study will be done as follows:
* Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center.
* Participants will take a single dose of BIIB141 as a tablet by mouth on Day 1.
* Participants will remain at their study research center for 6 days. During this time, the participants will be provided with an electric breast pump. This is so that the researchers can collect breastmilk samples before and after the participants take BIIB141. The researchers will also collect blood samples.
* After leaving the study research center, the participants will return every 2 days for the next 10 days for more tests and checkups.
* Finally, there will be a follow-up with a "lactation consultant" up to 30 days after each participant's last study visit. This is someone who can help participants with breastfeeding or pumping.
* Each participant will be in the study for up to 2.5 months.

Start Date18 Oct 2024

Sponsor / Collaborator

Reata Pharmaceuticals, Inc.

NCT06623890 / Not yet recruitingNot Applicable

An Observational, Multinational, Post-Marketing Registry of Omaveloxolone-Treated Patients With Friedreich's Ataxia

In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS®. This is a drug available for doctors to prescribe for people with Friedreich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found using a group called the Friedreich's Ataxia Global Clinical Consortium (FA GCC). This is a group of study research centers that help provide clinical care for people with FA.
The main objective of this study is to collect safety information in participants with FA who are being prescribed BIIB141 for the first time by their own doctors.
The main question researchers want to answer in this study is:
* How many participants had serious adverse events (SAEs)? An adverse event is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care.
* How many participants had adverse events (AEs) related to heart failure or liver damage caused by the drug?
Researchers will also learn more about :
• Why and when participants stopped treatment, left the study, or took more of the drug than was prescribed
This study will be done as follows:
* Participants will be screened to check if they can join the study.
* After joining the study, the participants must start treatment with BIIB141 within 6 months.
* During the study, each participant's doctor will decide how often the participant visits the study research center to check on their health. This will be based on the doctor's own clinical judgment and what is recommended by the drug's label. Most participants will visit their study research center at least once a year.
* Data from the participants' regular visits to their doctor will be collected at 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.
* Each participant will be in the study for up to 5 years.

Start Date01 Oct 2024

Sponsor / Collaborator

Reata Pharmaceuticals, Inc.

NCT06628687 / RecruitingNot Applicable

A Post-Marketing, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation

The primary objective of the study is to assess the risks associated with pregnancy and maternal complications in women with Friedreich's Ataxia (FA) exposed to omaveloxolone during pregnancy and/or lactation. The secondary objective is to assess the adverse effects on the developing fetus, neonate, and infant in women exposed to omaveloxolone during pregnancy and/or lactation.

Start Date01 Oct 2024

Sponsor / Collaborator

Reata Pharmaceuticals, Inc.

100 Clinical Results associated with Omaveloxolone

100 Translational Medicine associated with Omaveloxolone

100 Patents (Medical) associated with Omaveloxolone

Literatures (Medical) associated with Omaveloxolone

01 Dec 2024·International Immunopharmacology

RTA408 alleviates lipopolysaccharide-induced acute lung injury via inhibiting Bach1-mediated ferroptosis

Article

Author: Zhu, Minmin ; Zhang, Yanli ; Zhang, Yaru ; Pang, Qingfeng ; Wu, Yaxian ; Nie, Yunjuan ; Chen, Dan ; He, Shuai ; Ge, Longlong

The approved traditional Asian medicine RTA408 (Omaveloxolone) has demonstrated potent anti-inflammatory properties in the treatment of Friedreich's ataxia. However, its effect on lipopolysaccharide (LPS)-induced acute lung injury (ALI) remains poorly understood. This study aims to evaluate the effect of RTA408 on LPS-induced ALI and elucidate its underlying mechanisms. In this study, in vivo experiments demonstrated that RTA408 significantly ameliorated LPS-induced mouse ALI, characterized by reduced pathological damage and neutrophil infiltration as well as decreased lung edema of murine lung tissues. Moreover, LPS administration induced ferroptosis in ALI mice, evidenced by increased MDA levels, reduced GSH and SOD activity, and decreased expression of ferroptosis repressors (GPX4 and SLC7A11), whereas RTA408 reversed these changes. Consistently, RTA408 reduced ferroptosis and improved cell damage in LPS-stimulated MLE-12 cells, as evidenced by decreased ROS and MDA levels, increased SOD, GSH activity and ferroptosis repressors expression. Meanwhile, the protective effective of RTA408 on LPS-induced oxidative damage was blocked by ferroptosis inhibitor ferrostatin-1 (Fer-1). Mechanistic studies demonstrated that RTA408 inhibited the expression and nuclear translocation of Bach1, and the anti-ferroptosis effect was diminished by Bach1 siRNA or Bach1 knockout (Bach1^-/-) mice. Furthermore, Bach1^-/- mice exhibited attenuated ALI induced by LPS compared to wild-type (WT) mice, and the protective effect of RTA408 on LPS-challenged ALI was not observed in Bach1^-/- mice. In conclusion, our data suggested that RTA408 alleviates LPS-induced ALI by interfering Bach1-mediated ferroptosis and might be a novel candidate for LPS-induced ALI/ARDS therapy.

01 Dec 2024·Epilepsy & Behavior

Drug repurposing in status epilepticus

Review

Author: Walker, Matthew C

The treatment of status epilepticus (SE) has changed little in the last 20 years, largely because of the high risks and costs of new drug development for SE. Moreover, SE poses specific challenges to drug development, such as patient diversity, logistical hurdles, and the need for acute treatment strategies that differ from chronic seizure prevention. This has reduced the appetite of industry to develop new drugs in this area. Drug repurposing is an attractive approach to address this unmet need. It offers significant advantages, including reduced development time, lower costs, and higher success rates, compared to novel drug development. Here I demonstrate how novel methods integrating biological knowledge and computational methods can be applied to drug repurposing in status epilepticus. Biological approaches focus on addressing mechanisms underlying drug resistance in SE (using for example ketamine, tacrolimus and safinamide) and longer-term consequences (using for example omaveloxolone, celecoxib and losartan). Additionally, artificial intelligence platforms, such as ChatGPT, can rapidly generate promising drug lists, while in silico methods can analyze gene expression changes to predict molecular targets. Combining AI and in silico approaches has identified several candidate drugs, including metformin, sirolimus and riluzole, for SE treatment. Despite the promise of repurposing, challenges remain, such as intellectual property issues and regulatory barriers. Nonetheless, drug repurposing presents a viable solution to the high costs and slow progress of traditional drug development for SE. This paper is based on a presentation made at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures, in April 2024.

01 Oct 2024·The Journal of Clinical Pharmacology

Relative Bioavailability of Omaveloxolone When Capsules Are Sprinkled Over and Mixed in Applesauce Compared With Administration as Intact Omaveloxolone Capsules: A Phase 1, Randomized, Open‐Label, Single‐Dose, Crossover Study in Healthy Adults

Article

Author: Wells, Jason A. ; Hynes, Scott M. ; Goldsberry, Angie ; Henneghan, Patrick D. ; Khan, Seemi ; Wu, Tony ; Shinde, Aparna ; Wu, Lucy ; Murai, Masako ; Zahir, Hamim

AbstractOmaveloxolone (SKYCLARYS®) is approved for the treatment of Friedreich ataxia (FA) in patients aged ≥16 years in the United States and European Union (EU). The recommended dosage is 150 mg administered orally once daily as three 50‐mg capsules. However, some patients with FA may have oropharyngeal dysphagia or difficulty swallowing whole capsules; therefore, alternate method(s) of administration are needed. A Phase 1 clinical study in 32 healthy volunteers evaluated the relative bioavailability, safety, and tolerability of a single dose of omaveloxolone when capsule contents were sprinkled on and mixed in applesauce compared to when taken as intact capsules. Palatability when sprinkled on and mixed in applesauce was assessed with a questionnaire. After a single 150‐mg dose, the peak and overall exposures of omaveloxolone were similar irrespective of administration method, with the 90% CIs of the geometric least squares mean ratio (%) for maximum plasma concentration (Cmax), AUC0‐t, and AUC0‐∞ within the 80% to 125% reference intervals. Omaveloxolone was absorbed more slowly as intact capsules (median tmax, 10 h) compared with sprinkled capsule contents over applesauce (median tmax, 6 h). With chronic daily administration of omaveloxolone to treat FA, the 4‐h difference in tmax is not considered clinically relevant. Sprinkled omaveloxolone capsule contents on applesauce were well tolerated, with acceptable palatability and no serious adverse events. Given the similar systemic exposure when capsules were swallowed whole, sprinkling omaveloxolone capsule contents on and mixing in applesauce is a feasible alternative method of administering omaveloxolone and has been included in both the United States and EU prescribing information.

News (Medical) associated with Omaveloxolone

17 Sep 2024

·www.biospace.com

Biogen’s New Drug Submission for Omaveloxolone Accepted for Priority Review by Health Canada for the Treatment of Friedreich’s Ataxia

Friedreich’s ataxia is a rare, debilitating and life-shortening neuromuscular disease caused by genetic factors 1 If approved, omaveloxolone would be the only disease-specific treatment option for patients living with this progressive and challenging disease This New Drug Submission reflects Biogen’s commitment to advancing treatments for rare diseases and serving the unmet needs of Canadian patients TORONTO , Sept. 17, 2024 /CNW/ - Biogen Canada Inc. (Biogen) is pleased to announce today that Health Canada has accepted for priority review its New Drug Submission (NDS) for omaveloxolone, an innovative therapy for Friedreich’s ataxia for the treatment of adults and adolescents aged 16 years and older. This once-daily oral medication, if approved, would represent the only therapy specifically targeted for Friedreich’s ataxia, addressing a critical unmet treatment need in this patient population. “Friedreich’s ataxia is a devastating diagnosis that profoundly impacts the lives of patients and their families,” said Eric Tse , General Manager at Biogen Canada. “The omaveloxolone NDS acceptance marks a significant step forward for Canadian patients, offering hope and potential for a therapy that could help manage this debilitating neurodegenerative disorder. We look forward to working with Canadian health authorities to bring forward this promising treatment for those in need.” Friedreich’s ataxia is a rare, inherited condition that affects about 1 in 40,000 people and has a profound impact on their lives, causing a slow, progressive loss of muscle coordination, slurred speech, weakness, and sensory loss. 2 Symptoms typically begin in childhood or adolescence, and while the progression varies, it often leads to significant disability over time 2 with individuals becoming wheelchair-bound 8 to 10 years after disease onset. 1 The NDS for omaveloxolone is supported by efficacy and safety data from the placebo-controlled MOXIe Part 2 trial, which indicated that omaveloxolone significantly improved modified Friedreich Ataxia Rating Scale (mFARS) scores at 48 weeks relative to placebo. Omaveloxolone received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration, as well as Orphan Drug status by the European Commission. 3,4 It has received regulatory approval for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older in both the United States and the European Union, with strong support from the medical and patient communities. 3,4 In Canada , priority review submissions follow an accelerated timeline where the standard review period is shortened to 180 days. 5 A regulatory decision on the New Drug Submission for omaveloxolone is anticipated in early 2025. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment, to deliver long-term growth. Biogen has been proudly serving Canadian patients for more than 25 years. For information about Biogen Canada, please visit . References: Ataxia Canada . Friedreich’s Ataxia . Available at: Accessed September 2024 . AboutKidsHealth. Friedreich ataxia . Jan. 2020 . Available at: . Accessed September 2024 . U.S. Food and Drug Administration. (2023, February 28 ) FDA approves first treatment for Friedreich’s ataxia [press release] Accessed September 2024 . Biogen Inc. (2024, February 12 ) Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia [press release] Accessed September 2024 . Health Canada . Priority Review of Drug Submissions (Therapeutic Products) Available at: Accessed September 2024 . SOURCE Biogen Canada Inc.

Priority ReviewOrphan DrugDrug ApprovalFast Track

03 Jun 2024

·www.echemi.com

Neuroscience Takes Center Stage: MNCs Accelerate Investments in a Promising Field

The biopharmaceutical landscape is quietly undergoing a transformation, with neuroscience emerging as a hotspot amidst the industry's shifting dynamics. While the cancer therapy arena has seen setbacks with dual antibodies and ADCs, the metabolic disease space, led by weight loss treatments, has experienced a surge in popularity. Concurrently, the neuroscience (CNS) field is witnessing a renaissance, marked by clinical breakthroughs and a series of high-profile mergers and acquisitions. The renewed focus on neuroscience is driven by the immense unmet medical needs and recent advancements in fundamental research. According to WHO projections, neurological disorders are poised to become the second leading cause of death within the next 20 years. Alarmingly, the number of individuals diagnosed with Alzheimer's disease (AD) and other forms of dementia continues to rise, with an estimated 50 million people worldwide affected. Additionally, the prevalence of depression and severe mental illnesses is on the rise, with a worrying trend towards younger populations. Despite this growing burden, the efficacy of existing treatment options for neurological disorders remains below 50%, presenting a vast clinical demand and market potential. In this landscape, even minor therapeutic differences can lead to commercial success, as "you don't need a cure to have a blockbuster, just an incremental improvement." Moreover, the rapid advancements in sequencing technologies and the resulting drop in costs have enabled exponential growth in genetic research related to neurodegenerative diseases. By analyzing relevant genes, scientists have been able to identify critical signaling pathways and drug targets. The approval of Biogen's Aduhelm, the first Alzheimer's drug targeting the Aβ cascade, has served as a catalyst for the resurgence of the CNS field. Although Aduhelm faced challenges due to its significant side effects, leading to commercial failure, the recent full approval of Eisai and Biogen's Leqembi (lecanemab) in the United States and China marks a significant milestone. Leqembi is the first drug capable of slowing the progression of early-stage Alzheimer's disease, a landmark achievement in this notoriously difficult-to-treat field. Sensing the renewed promise of neuroscience, multinational corporations (MNCs) have accelerated their efforts to establish a presence in this space. However, the shadows of past failures have made them more cautious, leading them to favor low-risk, late-stage transactions that avoid the risks associated with early and mid-stage clinical trials. In 2022, Pfizer acquired Biohaven for $11.6 billion, gaining access to the migraine drug Nurtec ODT (rimegepant). In 2023, Pfizer's CGRP receptor antagonist nasal spray, Zavzpret, successfully obtained FDA approval. The neuroscience field has witnessed three major acquisition deals in 2023: Bristol Myers Squibb's $14 billion acquisition of Karuna Therapeutics, which provided the company with the schizophrenia drug KarXT; AbbVie's $8.7 billion purchase of Cerevel, securing the Parkinson's disease candidate Tavapadon and the schizophrenia and Alzheimer's psychosis candidate Emraclidine; and Biogen's $7.3 billion acquisition of Reata, gaining access to the Nrf2 activator Omaveloxolone for neurological indications. As the industry navigates the complexities of the neuroscience landscape, the promise of genetic research, advancements in AI-driven precision medicine, and the recent regulatory successes have ignited a renewed sense of optimism. The stage is set for MNCs to continue their aggressive pursuit of promising neuroscience assets, driven by the urgent need to address the growing burden of neurological disorders and the potential for significant commercial rewards.

AcquisitionDrug Approval

21 May 2024

·www.pharmaceutical-technology.com

Larimar resumes nomlabofusp programme after FDA lifts partial hold

The FDA lifted the partial clinical hold after reviewing Phase II dose escalation data. Image credit: Shutterstock/ Ismail Rajo. Larimar Therapeutics ’ clinical programme investigating nomlabofusp (CTI-1601) for the treatment of a neurodegenerative movement disorder is back on track after the US Food and Administration (FDA) lifted a partial clinical hold. Larimar is testing nomlabofusp in an open-label extension study for the treatment of patients with Friedreich’s ataxia – a genetic condition that causes progressive nervous system damage and movement impairment. The FDA lifted the partial clinical hold following a review of Phase II dose exploration data (NCT05579691), according to a 20 May press release by the US company. The FDA imposed a full clinical hold on the programme back in 2021 due to safety concerns with higher doses of the drug causing deaths in preclinical studies with non-human primates. In 2022, the FDA lifted the full clinical hold but kept a partial clinical hold, limiting trials to the 25mg dose. Shares in the biotech rose following the FDA’s decision, up 10% when the market opened on 21 May compared to the pre-announcement market close. See Also: FDA grants approval for two Eylea biosimilars for eye conditions FDA grants breakthrough therapy status for Nuvalent’s NVL-655 Nomlabofusp is a recombinant fusion protein that delivers human frataxin to cells. Patients with Friedreich’s ataxia are not able to make enough of this protein that is thought to play an important role in energy production in mitochondria. Larimar initially evaluated nomlabofusp at 25mg, dosing the first patient in March this year. After analysing frataxin pharmacodynamics at this dose, the biotech is planning to hike up the drug’s dose up to 50mg, for which it now has FDA clearance. Larimar’s CEO Carole Ben-Maimon said in a statement that interim data from the open-label extension study is expected in Q4 this year. The partial clinical hold was a blemish on the record for a drug that garnered multiple FDA awards, including rare paediatric disease designation, fast track designation and orphan drug designation. Nonetheless, Larimar touted positive results from the original Phase II study in February 2024. Data demonstrated that the nomlabofusp treatment over four weeks led to increases in frataxin levels in the skin and cells that line the cheeks and lips. Patients in the 50mg cohort had frataxin levels 33% higher than the control group’s average after two weeks. However, one participant in the 25mg cohort reported a severe adverse event for an allergic reaction and withdrew from the trial. The ongoing open-label extension study will add data on long-term safety and tolerability, pharmacokinetics, and peripheral tissue frataxin levels. Reata Pharmaceuticals won the race for the first approved therapy for Friedreich’s ataxia in the US, with its Skyclarys (omaveloxolone) receiving FDA approval in February last year. The oral capsules, which likely work by activating a pathway important in oxidative stress response, are approved to treat the disease in patients aged 16 years and above. Biogen assimilated the therapy into its portfolio following the acquisition of Reata in September 2023.

Phase 2Drug ApprovalOrphan DrugFast TrackClinical Result

100 Deals associated with Omaveloxolone

External Link

KEGG	Wiki	ATC	Drug Bank
D10964	Omaveloxolone	-	DB12513

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Friedreich Ataxia	US	Reata Pharmaceuticals, Inc.	28 Feb 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Friedreich Ataxia	NDA/BLA	CA	Biogen, Inc.	17 Sep 2024
Metastatic melanoma	Phase 2	US	Reata Pharmaceuticals, Inc.	31 Oct 2014
Unresectable Melanoma	Phase 2	US	Reata Pharmaceuticals, Inc.	31 Oct 2014
Breast Cancer	Phase 2	US	Reata Pharmaceuticals, Inc.	30 Jun 2014
Radiodermatitis	Phase 2	US	Reata Pharmaceuticals, Inc.	30 Jun 2014
Cataract	Phase 2	US	Reata Pharmaceuticals, Inc.	31 May 2014
Corneal Endothelial Cell Loss	Phase 2	US	Reata Pharmaceuticals, Inc.	31 May 2014
Ophthalmologic surgical procedures	Phase 2	US	Reata Pharmaceuticals, Inc.	31 May 2014
Eye Pain	Phase 2	US	Reata Pharmaceuticals, Inc.	28 Feb 2014
Ocular inflammation	Phase 2	US	Reata Pharmaceuticals, Inc.	28 Feb 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02128113 (CTgov)	Phase 2	Cataract \| Eye Pain \| Ocular inflammation \| Corneal Endothelial Cell Loss \| Ophthalmologic surgical procedures	307	Vehicle Ophthalmic Solution (Vehicle Ophthalmic Solution)	nopyziwtpb(haaafyiwzl) = jixbvsqkgy wmprnvdlop (gdewczlkqb, lujeynlpxn - rweufwgvou) View more	-	26 May 2023
				Omaveloxolone Ophthalmic Suspension 0.5% (Omaveloxolone Opthalmic Suspension 0.5%)	nopyziwtpb(haaafyiwzl) = lgsfimwpfl wmprnvdlop (gdewczlkqb, yzycbddulr - oaisuwecgi) View more
NCT02142959 (CTgov)	Phase 2	Breast Cancer \| Radiodermatitis	187	3D conformal radiation therapy+Omaveloxolone Lotion 0.5% (Omaveloxolone (RTA 408) Lotion 0.5%)	yjxoelamna(qwpmrurjbj) = vujeaplugx bdyfyeipod (brwjxlstav, qcgxxpflhn - mbetczzplc) View more	-	06 May 2023
				3D conformal radiation therapy+Omaveloxolone Lotion 3% (Omaveloxolone (RTA 408) Lotion 3%)	yjxoelamna(qwpmrurjbj) = cfhtupyfpd bdyfyeipod (brwjxlstav, hrzbyhpvuc - irrywikekd) View more
NCT02255435 (MOXIe, MDA2023) Manual	Phase 2	Friedreich Ataxia	103	Omaveloxolone 150 mg	(nrrmirxthe) = uzthlecmnk kzvjscnoxb (fgulaamqaq ) View more	Positive	19 Mar 2023
				Placebo	(nrrmirxthe) = uzakliptha kzvjscnoxb (fgulaamqaq ) View more
NCT02255435 (MOXIe, MDA2023)	Phase 2	Friedreich Ataxia Nrf2	-	Omaveloxolone	(csowigobie) = fffwwkjjoy xiyzkdgnbl (omlyecnhjh, 1.09) View more	Positive	19 Mar 2023
				Placebo	(csowigobie) = xamgjcpxlg xiyzkdgnbl (omlyecnhjh, 1.44) View more
NCT02255435 (FDA) Manual	Phase 2	Friedreich Ataxia	103	SKYCLARYS 150 mg	(jtezbrqauv) = dndimoxugl bjlvqhalyc (gopfsuzatq )	Positive	28 Feb 2023
				placebo	(jtezbrqauv) = zqbqpbdnpv bjlvqhalyc (gopfsuzatq )
NCT02255435 (MOXIe, Corporate Publications) Manual	Phase 2	Friedreich Ataxia	-	Omaveloxolone	(efftiaudgo): difference = -2.17±1.09 View more	Positive	08 Aug 2022
				Placebo
NCT02255435 (MOXIe, MDA2022)	Phase 2	Friedreich Ataxia Nrf2	-	Omaveloxolone	(ixwbvsmwpc) = blazbvxzjd glsjvrvsgd (rhucjoljxi, 1.45) View more	Positive	13 Mar 2022
				Placebo	(ixwbvsmwpc) = eepegdwjnx glsjvrvsgd (rhucjoljxi, 1.07) View more
NCT02259231 (CTgov)	Phase 1/2	Metastatic melanoma \| Unresectable Melanoma	41	Ipilimumab (3 mg/kg)+Omaveloxolone Capsules (2.5 mg/capsule) (Omaveloxolone 5 mg & Ipilimumab)	roxkppoiuz(nuarshpmuo) = qltguziruf bnfxkufzlz (yfbjuaallu, cmgmpetesi - bhysgkqptb) View more	-	24 Jun 2021
				Ipilimumab (3 mg/kg)+Omaveloxolone Capsules (10 mg/capsule) (Omaveloxolone 10 mg & Ipilimumab)	roxkppoiuz(nuarshpmuo) = ieyuoobibi bnfxkufzlz (yfbjuaallu, chhojykklf - rohzmlcujh) View more
NCT02255435 (MOXIe, Pubmed \| Ann Neurol) Manual	Phase 2	Friedreich Ataxia	103	Omaveloxolone	(vsvzrdrvpf) = dhnrhehbqz kkcwcjjqfx (rujhaghlxu, 0.69)	Positive	01 Feb 2021
				Placebo	(vsvzrdrvpf) = qzgequcgys kkcwcjjqfx (rujhaghlxu, 0.64)
NCT02255422 (MOTOR, CTgov)	Phase 2	Mitochondrial Myopathies	53	omaveloxolone capsules, 10 mg (Omaveloxolone Capsules 10 mg)	oqnypofuaf(jwgjearpcs) = wevwnanouy vkoikihjjf (tbzhcgyrnl, srhpvlkchc - lihqgwckrz) View more	-	17 Sep 2020
				omaveloxolone capsules, 20 mg (Omaveloxolone Capsules 20 mg)	oqnypofuaf(jwgjearpcs) = ngikrpbfdw vkoikihjjf (tbzhcgyrnl, cylqgkvcug - ssmqsqxyie) View more

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