RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Orphan Drug (Australia), Priority Review (Canada), Priority Review (United States)

Structure/Sequence

Molecular FormulaC33H44F2N2O3

InChIKeyRJCWBNBKOKFWNY-IDPLTSGASA-N

CAS Registry1474034-05-3

Clinical Trials associated with Omaveloxolone

NCT06628687

/ Not yet recruitingNot Applicable

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

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 Friedrich'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 have taken BIIB141 at any time during pregnancy and/or while breastfeeding or pumping up through the first year after delivery. Participants can join this study on their own or they may be enrolled by their regular doctors. This study is also known as the "SKYCLARYS (Omaveloxolone) Pregnancy and Lactation Surveillance Program."
The main objective of this study is to learn more about how BIIB141 may affect pregnancy, as well as any effects on the health of the mother and of the baby during its first year of life.
The main question researchers want to answer in this study is:
· Does taking BIIB141 during pregnancy or breastfeeding lead to any major birth defects?
Researchers will also learn more about:
* Does taking BIIB141 during pregnancy or breastfeeding lead to any minor birth defects?
* Does taking BIIB141 during pregnancy or breastfeeding affect the following:
* Gestational diabetes, a disease that can happen during pregnancy that affects how your body uses sugar
* Pre-eclampsia, a pregnancy-related high blood pressure disease
* Unborn baby being small for its expected age (usually in weeks)
* Loss of an unborn baby
* Live birth
* Premature birth
* Loss of a newborn
* Growth or developmental delays in the baby
* Serious illness in the baby resulting in hospitalization
* Serious infections in the baby, or ones in babies with a weakened immune system
This study will be done as follows:
* Participants will join the study after signing an informed consent form, also known as an ICF.
* During the study, health information from the participants' regular visits to their doctor will be collected based on whether participant joined the study while pregnant or after the baby is born.
* Each participant will be in the study for up to 1 year after the birth of their child, unless they decide to leave early. Overall, this study is expected to last at least 10 years.

Start Date26 Oct 2026

Sponsor / Collaborator

Biogen, Inc.

NCT06623890

/ 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) UNIFIED Natural History Study (UNIFAI). The FA-GCC is a group of study research centers that helps provide clinical care for FA patients and also helps researchers learn more about how FA affects patients over a long time.
The main objective of this study is to collect safety information in participants with FA from UNIFAI. Some of the participants in this study will be prescribed BIIB141 for the first time by their own doctors. Some of the participants will have started taking BIIB141 after joining UNIFAI, but less than 12 months before joining this study.
The main questions researchers want to answer in this study are:
* 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 who had never started BIIB141 treatment before must start it within 6 months. Otherwise, all participants will take BIIB141 throughout this study as prescribed by their own doctor.
* 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.
* 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 Date12 Dec 2024

Sponsor / Collaborator

Biogen, Inc.

NCT06612879

/ Active, not recruitingPhase 1

An Open-Label, Single Dose Study to Assess the Breast Milk and Plasma Pharmacokinetics of Omaveloxolone (BIIB141) in Healthy Lactating Women

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

Biogen, Inc.

100 Clinical Results associated with Omaveloxolone

100 Translational Medicine associated with Omaveloxolone

100 Patents (Medical) associated with Omaveloxolone

119

Literatures (Medical) associated with Omaveloxolone

01 Apr 2025·Redox Biology

Nrf2 activators for the treatment of rare iron overload diseases: From bench to bedside

Review

Author: Dong, Yimin ; Ding, Weizhong ; Xiao, Jun ; Zheng, Meng ; Li, Feng ; Guan, Hanfeng

Iron overload and related oxidative damage are seen in many rare diseases, due to mutation of iron homeostasis-related genes. As a core regulator on cellular antioxidant reaction, Nrf2 can also decrease systemic and cellular iron levels by regulating iron-related genes and pathways, making Nrf2 activators very good candidates for the treatment of iron overload disorders. Successful examples include the clinical use of omaveloxolone for Friedreich's Ataxia and dimethyl fumarate for relapsing-remitting multiple sclerosis. Despite these uses, the therapeutic potentials of Nrf2 activators for iron overload disorders may be overlooked in clinical practice. Therefore, this study talks about the potential use, possible mechanisms, and precautions of Nrf2 activators in treating rare iron overload diseases. In addition, a combination therapy with Nrf2 activators and iron chelators is proposed for clinical reference, aiming to facilitate the clinical use of Nrf2 activators for more iron overload disorders.

01 Apr 2025·Nature Reviews Neurology

A global perspective on research advances and future challenges in Friedreich ataxia

Review

Author: Rai, Myriam ; Delatycki, Martin B ; Indelicato, Elisabetta ; Boesch, Sylvia ; Farmer, Jennifer ; França, Marcondes C ; Perlman, Susan

Friedreich ataxia (FRDA) is a rare multisystem, life-limiting disease and is the most common early-onset inherited ataxia in populations of European, Arab and Indian descent. In recent years, substantial progress has been made in dissecting the pathogenesis and natural history of FRDA, and several clinical trials have been initiated. A particularly notable recent achievement was the approval of the nuclear factor erythroid 2-related factor 2 activator omaveloxolone as the first disease-specific therapy for FRDA. In light of these developments, we review milestones in FRDA translational and clinical research over the past 10 years, as well as the various therapeutic strategies currently in the pipeline. We also consider the lessons that have been learned from failed trials and other setbacks. We conclude by presenting a global roadmap for future research, as outlined by the recently established Friedreich's Ataxia Global Clinical Consortium, which covers North and South America, Europe, India, Australia and New Zealand.

01 Mar 2025·Disease Models & Mechanisms

Robust behavioral assessment of the inducible Friedreich's ataxia mouse does not show improvement with NRF2 induction

Article

Author: Dedkova, Elena N. ; Salinas, Lili ; Montgomery, Claire B. ; Figueroa, Francisco ; Adcock, Lauren E. ; Cox, Garrett P. ; Chang, Tiffany ; Cortopassi, Gino

ABSTRACT:

Friedreich's ataxia, a recessive disorder caused by a mutation in the frataxin (FXN) gene, has few mouse models that demonstrate a progressive behavioral decline paralleling that of patients. A mouse model of systemic frataxin deficiency, the FXNKD, was recently developed using a doxycycline-inducible method; it is thought to mimic the patient phenotype seen when frataxin levels are decreased, but it has not been determined whether it is reliable for assessment of therapeutics. FXNKD mice underwent testing for 12 weeks alongside littermates, undergoing tests of motor function, gait and sensation. Additionally, a subset underwent treatment with omaveloxolone or dimethyl fumarate, both NRF2 inducers. We identified multiple techniques that sensitively detect decline in the mice, including open field, gait analysis and Von Frey tests. Furthermore, we developed a novel Salinas–Montgomery ataxia scale, which allows for more comprehensive assessment than a four-part cerebellar ataxia scale. Despite validating multiple sensitive techniques, we did not see any benefits of NRF2-inducing therapies in any tests. This was exacerbated by the discovery of a sexual dimorphism in FXNKD mice, in which males show more significant decline and better responsiveness to NRF2-inducing therapeutics.

News (Medical) associated with Omaveloxolone

18 Mar 2025

·www.pharmaceutical-technology.com

Health Canada approves Biogen’s Skyclarys for Friedreich’s ataxia

Biogen’s therapy previously secured an orphan drug designation for FA treatment. Credit: Piotr Swat/Shutterstock. Health Canada has granted approval for Biogen’s Skyclarys (omaveloxolone) to treat Friedreich’s ataxia (FA), a rare, progressive neurodegenerative disease, in individuals aged 16 years and above. The approval, achieved through the priority review process, marks the therapy as the sole treatment in the country targeting the underlying mechanisms of FA. The Canadian regulator’s approval is supported by the pivotal MOXIe Part 2 trial. This placebo-controlled trial included more than 100 subjects. Post 48 weeks, subjects who were given the therapy showed an improvement in their modified FA Rating Scale (mFARS) scores. The oral medication has secured rare paediatric disease, orphan drug and fast track designations from the US Food and Drug Administration (FDA). The European Commission has granted the therapy orphan drug status for the treatment of FA in Europe. FA affects around one in 40,000 people in the country, causing progressive damage to the peripheral nerves and spinal cord, and to the regions of the brain responsible for balance, speech and movement. Symptoms usually appear in childhood or adolescence and progressively worsen. Biogen Canada general manager Eric Tse stated: “The approval of Skyclarys in Canada represents a pivotal moment in our ongoing commitment to advancing treatment options for rare diseases, particularly those with limited treatment options and high unmet needs. “We are incredibly proud to introduce the only Health Canada-approved treatment for FA. We remain steadfast in our dedication to working alongside the medical and patient communities and with payors across Canada to ensure Skyclarys is accessible to individuals living with this challenging condition.” In February 2025, Biogen entered into a collaboration with Stoke Therapeutics, aiming to develop and commercialise zorevunersen for the treatment of Dravet syndrome in all territories outside of Canada, Mexico and the US.

Orphan DrugClinical ResultDrug ApprovalFast TrackClinical Study

05 Feb 2025

·www.prnewswire.com

Rare Disease Patients Face Barriers in Access and Care

People with Friedreich's ataxia face debilitating symptoms, too few medical specialists and too many health insurance barriers, physicians explain in new policy paper WASHINGTON, Feb. 5, 2025 /PRNewswire/ -- An FDA-approved medication can now treat Friedreich's ataxia, but health plan barriers and formulary exclusions keep many patients from receiving it. In a white paper by the Alliance for Patient Access and the Friedreich's Ataxia Research Alliance, titled "Friedreich's Ataxia: A Rare Condition Facing Common Access Challenges," physician authors outline the disease's debilitating symptoms as well as the treatment challenges that accompany it. The rare genetic condition often begins in childhood and affects the brain, heart and neurological system. Continue Reading Alliance for Patient Access logo. (PRNewsfoto/Alliance for Patient Access) After years with no dedicated treatment option, the FDA approved omaveloxolone in 2023. Hailed as "an exciting step forward for the FA community," the medication remains out of reach for many patients. Some health plans have excluded the new drug from their formulary. Others cover it but only with onerous prior authorization and step therapy protocols, which delay care for patients already struggling with the disease's symptoms. These barriers compound existing challenges. Finding a specialist or clinician who can diagnose Friedreich's ataxia, given its rarity, remains difficult. Clinician knowledge gaps and transportation challenges often mean delayed diagnosis or misdiagnosis. "Due to the progressive nature of Friedreich's ataxia, people living with the condition cannot afford delays in access to knowledgeable healthcare professionals or treatment," says Kellyn Madden, patient engagement manager for the Friedreich's Ataxia Research Alliance. "The FA community has partnered for many years with researchers to bring treatments forward. This white paper marks a significant step in raising awareness and advocating for policies that facilitate access to this care." The white paper proposes several potential policy solutions, including: Limits on health plan utilization management Expanded coverage for telehealth Support for innovation and more opportunities for children to participate in clinical trials STATEMENT FROM JOSIE COOPER, EXECUTIVE DIRECTOR OF THE ALLIANCE FOR PATIENT ACCESS: "Patients with Friedreich's ataxia deserve access to innovative treatments and patient-centered care. With health plan barriers negatively impacting these patients' physical and mental health, policy change is critical." Learn more in "Friedreich's Ataxia: The Rare Condition Facing Common Access Challenges." About the Alliance for Patient Access The Alliance for Patient Access is a network of policy-minded health care providers who advocate for patient-centered care. About the Friedreich's Ataxia Research Alliance The Friedreich's Ataxia Research Alliance (FARA) is a national, public, 501(c)(3), nonprofit, organization dedicated to the pursuit of scientific research leading to treatments and a cure for Friedreich's ataxia. SOURCE Alliance for Patient Access WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

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

100 Deals associated with Omaveloxolone

External Link

KEGG	Wiki	ATC	Drug Bank
D10964	Omaveloxolone	-	DB12513

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Friedreich Ataxia	United States	Biogen U.S. Corp.	28 Feb 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mitochondrial Myopathies	Phase 2	United States	Reata Pharmaceuticals, Inc.	05 May 2015
Mitochondrial Myopathies	Phase 2	Denmark	Reata Pharmaceuticals, Inc.	05 May 2015
Metastatic melanoma	Phase 2	United States	Reata Pharmaceuticals, Inc.	31 Oct 2014
Unresectable Melanoma	Phase 2	United States	Reata Pharmaceuticals, Inc.	31 Oct 2014
Breast Cancer	Phase 2	United States	Reata Pharmaceuticals, Inc.	30 Jun 2014
Radiodermatitis	Phase 2	United States	Reata Pharmaceuticals, Inc.	30 Jun 2014
Cataract	Phase 2	United States	Reata Pharmaceuticals, Inc.	31 May 2014
Corneal Endothelial Cell Loss	Phase 2	United States	Reata Pharmaceuticals, Inc.	31 May 2014
Ophthalmologic surgical procedures	Phase 2	United States	Reata Pharmaceuticals, Inc.	31 May 2014
Eye Pain	Phase 2	United States	Reata Pharmaceuticals, Inc.	28 Feb 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MDA2024	Phase 1	-	32	Omaveloxolone Intact Capsules	wincgnkchk(rwlnuxlxvf) = lpiqsunmay sjlersxgcp (cfvbpajhbu, 17.2) View more	Positive	03 Mar 2024
				Omaveloxolone Sprinkled on Applesauce	wincgnkchk(rwlnuxlxvf) = sdlsspcpkg sjlersxgcp (cfvbpajhbu, 19.7) View more
NCT02128113 (CTgov)	Phase 2	Cataract \| Eye Pain \| Ocular inflammation ... View more	307	Vehicle Ophthalmic Solution (Vehicle Ophthalmic Solution)	hmsuoqjxnj(vhatbvgchj) = sfqnuhaaaa wzakpdhzku (cdmhxayshj, 340.58) View more	-	26 May 2023
				Omaveloxolone Ophthalmic Suspension 0.5% (Omaveloxolone Opthalmic Suspension 0.5%)	hmsuoqjxnj(vhatbvgchj) = sshzlfrlwg wzakpdhzku (cdmhxayshj, 237.00) View more
NCT02142959 (CTgov)	Phase 2	Breast Cancer \| Radiodermatitis	187	3D conformal radiation therapy+Omaveloxolone Lotion 0.5% (Omaveloxolone (RTA 408) Lotion 0.5%)	cukytdyvoz(qmtldhepyc) = cdkjtgwtsp clukhvewmk (tszgsylmfl, zgbndbmmrk - lkwifbxyjs) View more	-	06 May 2023
				3D conformal radiation therapy+Omaveloxolone Lotion 3% (Omaveloxolone (RTA 408) Lotion 3%)	cukytdyvoz(qmtldhepyc) = ztyrrhqwsl clukhvewmk (tszgsylmfl, wrvqwxfluc - etpeeegagm) View more
NCT02255435 (MOXIe, MDA2023) Manual	Phase 2	Friedreich Ataxia	103	Omaveloxolone 150 mg	gqhaqaypue(eoyfukbeod) = hwtogzeifm vsadxibamp (umvbopeawm ) View more	Positive	19 Mar 2023
				Placebo	gqhaqaypue(eoyfukbeod) = eyakbdoiwj vsadxibamp (umvbopeawm ) View more
NCT02255435 (MOXIe, MDA2023)	Phase 2	Friedreich Ataxia Nrf2	-	Omaveloxolone	byyqhuggla(lhyuvjmbdd) = ujtorgywgp ftrxoprgdy (esmgacqobm, 1.09) View more	Positive	19 Mar 2023
				Placebo	byyqhuggla(lhyuvjmbdd) = ovezrcytkv ftrxoprgdy (esmgacqobm, 1.44) View more
NCT02255435 (FDA) Manual	Phase 2	Friedreich Ataxia	103	SKYCLARYS 150 mg	ztkhjqhrzp(crfqwrgppz) = etiwtskkpu xchmftpfpl (gbeluqvfby )	Positive	28 Feb 2023
				placebo	ztkhjqhrzp(crfqwrgppz) = bdxicodfiy xchmftpfpl (gbeluqvfby )
NCT02255435 (MOXIe, Corporate Publications) Manual	Phase 2	Friedreich Ataxia	-	Omaveloxolone	vrpyxcbnaw(jvdouwlgmb): difference = -2.17±1.09 View more	Positive	08 Aug 2022
				Placebo
NCT02255435 (MOXIe, MDA2022)	Phase 2	Friedreich Ataxia Nrf2	-	Omaveloxolone	xtugcksjxr(bionajjpjy) = bktbhnoezd lelpbhuimd (khcmeyddnl, 1.45) View more	Positive	13 Mar 2022
				Placebo	xtugcksjxr(bionajjpjy) = bohllguqsu lelpbhuimd (khcmeyddnl, 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)	dfnegtrbbq = btbskmykyo kdivklrgle (cytjgxupzq, kgzlxdrzpj - irxgglnqjv) View more	-	24 Jun 2021
				Ipilimumab (3 mg/kg)+Omaveloxolone Capsules (10 mg/capsule) (Omaveloxolone 10 mg & Ipilimumab)	dfnegtrbbq = izngombwxg kdivklrgle (cytjgxupzq, qgxlqsikam - vfcpjwermp) View more
NCT02255435 (MOXIe, Pubmed \| Ann Neurol) Manual	Phase 2	Friedreich Ataxia	103	Omaveloxolone	jiozerrcmv(hzxzijnkma) = nkihnddhdn gdessllffc (gncmpnopod, 0.69)	Positive	01 Feb 2021
				Placebo	jiozerrcmv(hzxzijnkma) = rdnhszulfa gdessllffc (gncmpnopod, 0.64)

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