Biogen

Biogen works on 31 rare diseases tracked on Trial Friend, including Alport Syndrome, Amyotrophic Lateral Sclerosis, Angelman Syndrome and 28 more, with 34 recruiting clinical trials and 9 FDA-approved rare disease drugs.

Biogen is a neurobiological company with strong focus on rare neurodegenerative and neurological diseases including spinal muscular atrophy, Friedreich's ataxia, and ALS. The company develops disease-modifying therapies for rare inherited neurological conditions.

Type
Diversified Pharma
Ticker
BIIB
Headquarters
Cambridge, United States
Founded
1978
Website
biogen.com
34
Active Rare Disease Trials
9
Approved Rare Disease Drugs
31
Rare Diseases in Portfolio
48
Years Active

Focus areas at Biogen

Within its broader pharmaceutical portfolio, Biogen has active clinical trial programs and drug development efforts across 31 rare diseases, including Alport Syndrome, Amyotrophic Lateral Sclerosis, Angelman Syndrome, Dermatomyositis, Eosinophilic Granulomatosis with Polyangiitis, and 26 additional rare conditions. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Biogen, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Biogen is headquartered in Cambridge, United States, founded in 1978, publicly traded under the ticker symbol BIIB. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Biogen Drug Pipeline

Biogen has 34 active clinical trials across 5 development stages, with 34 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Biogen's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Biogen's pipeline
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4
Early Phase / Phase 14 trials
Muscular Atrophy, Spinal
Recruiting
Healthy Volunteer
Recruiting
Healthy Volunteer+1 more
Recruiting
2
Phase 22 trials
9
Phase 39 trials
Muscular Atrophy, Spinal
Recruiting
Muscular Atrophy, Spinal
Recruiting
1
Phase 4 / Post-Market1 trial
18
Other18 trials
Muscular Atrophy, Spinal
Recruiting
Recruiting
Recruiting

Biogen Clinical Trials (34)

Active and recruiting clinical trials sponsored by Biogen, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Biogen's trials
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RECRUITINGPHASE3Recently updatedNCT06962800

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Intervention: Felzartamab, Tacrolimus, Standard of Care IST

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease. The main question that researchers want to answer is: * How many participants achieve a complete response after 104 weeks of treatment? * A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable. Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * How many participants develop antibodies against felzartamab in the blood? * How many participants achieve a complete response after 76 weeks of treatment * How many participants have medical problems during the study * How felzartamab is processed by the body * How felzartamab affects participants' tiredness and overall physical health The study will be done as follows: * Participants will be screened to check if they can join the study. This may take up to 42 days. * Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets. * If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment. * If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104. * In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Ages 18 Years - 80 Years114 locations
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT03958877

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Intervention: BIIB017 (peginterferon beta-1a), Interferon beta type 1a

This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.

Ages 10 Years - 18 Years65 locations
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RECRUITINGNARecently updatedNCT07444333

Cardiac Output and Fatigue in Friedreich's Ataxia

Intervention: Aerobic Exercise

This is a clinical trial examining to impact of aerobic training plus omaveloxolone in FRDA. Thirty individuals with FRDA will be recruited; 20 individuals will be on omaveloxolone treatment whereas the other ten individuals will not. Individuals will undergo baseline assessment including cardiopulmonary exercise testing (CPET), mFARS, gait speed, Timed Up and Go (TUG), Fatigue Severity Scale (FSS), Fatigue Impact Scale (FIS), and 6-minute Walk Test (6MWT). Individuals will then perform 3-months of home aerobic training. Repeat assessments will be conducted at 3- and 6-months.

Ages not specified1 location
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RECRUITINGPHASE3Recently updatedNCT06935357

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)

Intervention: Felzartamab, Placebo

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: * Participants will be screened to check if they can join the study. * Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know what the participants will receive. * Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. * Afterwards, participants will enter a follow-up period which will last 80 weeks. * In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

Ages 18 Years+261 locations
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ACTIVE NOT RECRUITINGRecently updatedNCT05042921

Pediatric Spinal Muscular Atrophy (SMA) China Registry

Muscular Atrophy, Spinal

The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) treatments among pediatric Chinese participants with spinal muscular atrophy linked to chromosome 5q (5q-SMA). The study will examine SMA natural history and DMT outcomes in a real-world setting both prospectively and retrospectively.

Ages Up to 18 Years25 locations
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RECRUITINGPHASE1Recently updatedNCT06555419

A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)

Intervention: Nusinersen, ThecaFlex DRx System

Muscular Atrophy, Spinal

In this PIERRE-PK study, researchers will learn how the body processes nusinersen when it is given through the ThecaFlex DRx™ System, compared to when nusinersen is given by lumbar puncture (LP). The ThecaFlex DRx system is an investigational implantable medical device developed by Alcyone Therapeutics, Inc. It consists of a catheter, which is a flexible tube, connected to a port which is placed under the skin. Alcyone Therapeutics, Inc. has an ongoing study called PIERRE to test the ThecaFlex DRx system. Participants with spinal muscular atrophy (SMA) in the PIERRE study may be enrolled in the PIERRE-PK study. The main goal of the PIERRE-PK study is to learn how the body processes nusinersen when given by the ThecaFlex DRx system compared to a lumbar puncture. The main questions researchers want to answer are: * What is the highest amount of nusinersen found in the blood after dosing? * How much nusinersen is found in the blood over the first 24 hours after dosing? The PIERRE-PK 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 30 days for this study and may overlap with the PIERRE study. * Participants will join 1 of 2 groups based on their ongoing nusinersen treatment. One group will be receiving 12 mg doses of nusinersen. The other group will be receiving 28 mg doses of nusinersen. * Participants will first receive a dose of nusinersen by lumbar puncture. * The ThecaFlex DRx system will be implanted after the lumbar puncture, as part of the PIERRE study. * Participants will receive a dose of nusinersen by the ThecaFlex DRx system, as part of the PIERRE study. This dose will be a regular maintenance dose that happens about 4 months after their first dose in this study. * Researchers will take blood samples before and after each dose. The last blood sample will be taken 24 hours after the dose. * The total study duration for each participant in the PIERRE-PK study will be approximately 5 months. This period will overlap with the participant's first 5 months in the PIERRE study.

Ages 3 Years+21 locations
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ACTIVE NOT RECRUITINGPHASE1Recently updatedNCT06054893

A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old

Intervention: Omaveloxolone

In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at least 16 years old. But, it is not yet available for children and teens with FA who are younger than 16 years old. The main goal of this study is to learn how BIIB141 is processed in the body of children and teens who are 2 to 15 years old. The main question researchers want to answer in this study is: * How does the body process BIIB141 in children and teens? * How many participants have medical problems during the study? * Are there any changes in the participants' overall health during the study? * Are there any changes in the participants' heart health? * Are there any changes in how the participants move through puberty? Puberty is the time in someone's life when their body changes from a child to an adult. This study will be done as follows: * Participants will be screened to see if they can join the study. The screening period will be up to 14 days, after which participants will check into their study research center. * There are 2 parts to this study. During Part 1, participants will take a single dose of BIIB141. Participants will be in 1 of 7 different groups based on their age: * Group A1: 12 to 15 years old, taking 150 milligrams (mg) of BIIB141 * Group A2: 12 to 15 years old, taking a dose of BIIB141 based on the data from Group A1 * Group B1: 7 to 11 years old, taking a dose of BIIB141 based on Group A1 data * Group C1: 2 to 6 years old, taking a dose of BIIB141 based on Groups A1, A2, and B1 data * Group A3: 12 to 15 years old, taking a dose of BIIB141 based on Groups A1, A2, and B1 data * Group B2: 7 to 11 years old, taking a dose of BIIB141 based on Groups A1, A2, and B1 data * Group C2: 2 to 6 years old, taking a dose of BIIB141 based on Group A1, A2, A3, B1, B2, and C1 data. * During Part 2, participants from Part 1 will take BIIB141 once in the study research center. Cohort A1 will take 150 mg of BIIB141. Dose of Cohorts A2 and B1 will be based on data from Cohort A1, dose of Cohorts C1, A3 and B2 will be based on data from Cohorts A1, A2 and B1, while Cohort C2's dose will be based on all the other groups. Participants will then take it once a day at home. * After leaving the study research center in Part 2, participants will return for tests at Week 4, Week 12, Week 24, and then every 24 weeks. Participants will also be contacted by telephone at Week 2, Week 8, and Week 18, and about 30 days after their last dose of the study drug. * Participants will be in this study for up to 302 weeks.

Ages 2 Years - 15 Years1 location
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Biogen FDA-Approved Drugs (9)

Medications developed or marketed by Biogen that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
INTERFERON BETA-1A
Interferon beta [EPC]
Avonex
intramuscular
May 17, 1996
PEGINTERFERON BETA-1A
Interferon beta [EPC]
Plegridy Pen
subcutaneous, intramuscular
Aug 15, 2014
TOFERSEN
Antisense Oligonucleotide [EPC]
QALSODY
intrathecal
Apr 25, 2023
OMAVELOXOLONESKYCLARYS
oral
Feb 28, 2023
NUSINERSEN
Survival Motor Neuron-2-directed RNA Interaction [EPC]
Spinraza
intrathecal
Dec 23, 2016

Biogen Trial Locations

Biogen clinical trials are running at 723 sites in 43 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
132▼
China
113▼
United Kingdom
45▼
Japan
39▼
India
30▼
Italy
30▼
Germany
29▼
Australia
26▼
Spain
24▼
France
23▼
Brazil
22▼
Taiwan
18▼

Rare Disease Focus Areas (31)

Diseases targeted by Biogen's clinical trial and drug development programs

Alport SyndromeKidney & Renal

Alport Syndrome is a genetic disorder that causes progressive damage to the kidneys, ears, and eyes due to defects in a type of collagen that provides structure and flexibility to tissues. The conditi...

Prevalence: Approximately 1 in 5,000 to 10,000 people worldwide
Amyotrophic Lateral SclerosisNeurological & Neuromuscular

Amyotrophic lateral sclerosis is a progressive neurodegenerative disease destroying motor neurons in the brain and spinal cord. This causes progressive weakness and paralysis of voluntary muscles whil...

Prevalence: About 5,000 new cases per year in the U.S.; approximately 16,000 Americans living with ALS at any given time
Angelman SyndromeNeurological & Neuromuscular

Angelman Syndrome is a rare neurological disorder caused by loss of function of the UBE3A gene on the maternal chromosome 15. People with this condition typically develop normal until 6-12 months of a...

Prevalence: Approximately 1 in 12,000 to 20,000 people
DermatomyositisAutoimmune & Inflammatory

Dermatomyositis is a rare autoimmune inflammatory disease causing muscle weakness and distinctive skin rashes, particularly over joints. It involves inflammation of muscles and skin blood vessels. Abo...

Prevalence: Approximately 1-10 cases per million people; juvenile-onset incidence about 0.4 cases per 100,000 children
Eosinophilic Granulomatosis with PolyangiitisAutoimmune & Inflammatory

Eosinophilic granulomatosis with polyangiitis (EGPA, formerly Churg-Strauss syndrome) is a systemic necrotizing vasculitis characterized by asthma, blood eosinophilia, and inflammation of small- and m...

Prevalence: 10 to 14 cases per million people; approximately 3,000 to 4,500 individuals in the U.S.
Inherited ErythromelalgiaNeurological & Neuromuscular

Inherited erythromelalgia is a rare autosomal dominant pain disorder caused by gain-of-function mutations in the SCN9A gene, which encodes the Nav1.7 voltage-gated sodium channel. Patients experience ...

Prevalence: Overall erythromelalgia prevalence is approximately 10 per 100,000; the inherited SCN9A-related form accounts for 5-15% of cases, affecting an estimated 1,600 to 5,000 people in the U.S.

Patient Resources

Organizations and resources related to Biogen's rare disease focus areas

Frequently Asked Questions About Biogen

Common questions about Biogen's rare disease programs, clinical trials, and treatments.