Roche Holding AG / Genentech

Roche Holding AG / Genentech works on 63 rare diseases tracked on Trial Friend, including Adrenocortical Carcinoma, Amyotrophic Lateral Sclerosis, Angelman Syndrome and 60 more, with 71 recruiting clinical trials and 25 FDA-approved rare disease drugs.

Roche, through its subsidiary Genentech, develops therapies across oncology, immunology, neurology, and rare diseases. The company applies its expertise in biotechnology and precision medicine to address rare genetic and complex diseases with limited treatment options.

Type
Diversified Pharma
Ticker
RHHBY
Headquarters
Basel, Switzerland
Founded
1896
Website
roche.com
71
Active Rare Disease Trials
25
Approved Rare Disease Drugs
63
Rare Diseases in Portfolio
130
Years Active
FDA decision ahead
The FDA is due to decide on Gazyva (obinutuzumab) for Primary membranous nephropathy in By November 2026.
The FDA is due to decide on Enspryng (satralizumab) for MOG antibody-associated disease (MOGAD) by January 10, 2027.
See all upcoming rare disease FDA decisions →

Focus areas at Roche Holding AG / Genentech

Within its broader pharmaceutical portfolio, Roche Holding AG / Genentech has active clinical trial programs and drug development efforts across 63 rare diseases, including Adrenocortical Carcinoma, Amyotrophic Lateral Sclerosis, Angelman Syndrome, Atypical Hemolytic Uremic Syndrome, Autoimmune Hepatitis, and 58 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 Roche Holding AG / Genentech, 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.

Roche Holding AG / Genentech is headquartered in Basel, Switzerland, founded in 1896, publicly traded under the ticker symbol RHHBY. 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.

Roche Holding AG / Genentech Drug Pipeline

Roche Holding AG / Genentech has 71 active clinical trials across 5 development stages, with 71 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 Roche Holding AG / Genentech'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 Roche Holding AG / Genentech's pipeline
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8
Early Phase / Phase 18 trials
B-Cell Lymphoma, Unspecified+4 more
Recruiting
Sarcoma+1 more
Recruiting
Non-cystic Fibrosis Bronchiectasis+1 more
Recruiting
Locally Advanced or Metastatic Solid Tumors+4 more
Recruiting
23
Phase 223 trials
20
Phase 320 trials
Recruiting
Moderately to Severely Active Ulcerative Colitis
Recruiting
7
Phase 4 / Post-Market7 trials
Muscular Atrophy, Spinal
Recruiting
Muscular Atrophy, Spinal
Recruiting
13
Other13 trials

Roche Holding AG / Genentech Clinical Trials (71)

Active and recruiting clinical trials sponsored by Roche Holding AG / Genentech, 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 Roche Holding AG / Genentech's trials
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT04544436

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Intervention: Ocrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone

This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Ages 18 Years - 55 Years120 locations
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ACTIVE NOT RECRUITINGPHASE2Recently updatedNCT05119569

A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Intervention: Fenebrutinib, Placebo

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two parts: Double-blind treatment (DBT) phase and an optional Open-label extension (OLE) phase.

Ages 18 Years - 55 Years17 locations
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ACTIVE NOT RECRUITINGPHASE1Recently updatedNCT02992522

Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Intervention: Lenalidomide, Obinutuzumab, Venetoclax

B-Cell Lymphoma, UnspecifiedGrade 1 Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular LymphomaRecurrent Burkitt Lymphoma

This phase I study studies the side effects and best dose of venetoclax and lenalidomide when given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of improvement or not responding to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may work better in treating patients with B-cell non-Hodgkin lymphoma.

Ages 18 Years+2 locations
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RECRUITINGPHASE3Recently updatedNCT07416526

A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A

Intervention: NXT007, Human Coagulation Factor VIII

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.

Ages 12 Years+32 locations
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT04586010

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Intervention: Fenebrutinib, Teriflunomide, Placebo

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.

Ages 18 Years - 55 Years158 locations
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ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT04586023

Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Intervention: Fenebrutinib, Teriflunomide, Placebo

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.

Ages 18 Years - 55 Years106 locations
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RECRUITINGPHASE2Recently updatedNCT05626114

A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251

Intervention: OpRegen

This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated. The substudy will evaluate the operational feasibility and scientific interpretability of incorporating AO retinal imaging using the EarlySight Cellularis® Discovery device. Participants who have fulfilled the eligibility requirements for the parent study and meet the substudy's eligibility criteria will have the option to participate in the substudy. The EarlySight Cellularis® Discovery device will be used only as an assessment tool and data obtained from this device will not be used to guide clinical care or influence clinical outcomes for participants.

Ages 50 Years+17 locations
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Roche Holding AG / Genentech FDA-Approved Drugs (25)

Medications developed or marketed by Roche Holding AG / Genentech 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
TOCILIZUMAB
Interleukin-6 Receptor Antagonist [EPC]
ACTEMRA
intravenous, subcutaneous
Jan 8, 2010
ALTEPLASEActivaseNov 13, 1987
ALECTINIB HYDROCHLORIDEALECENSA
oral
Dec 11, 2015
BEVACIZUMAB
Vascular Endothelial Growth Factor Inhibitor [EPC]
Avastin
intravenous
Feb 26, 2004
ALTEPLASECathflo Activase
intravenous
Nov 13, 1987

Roche Holding AG / Genentech Trial Locations

Roche Holding AG / Genentech clinical trials are running at 2,638 sites in 60 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
650▼
Italy
216▼
China
157▼
Poland
150▼
Spain
133▼
Japan
130▼
France
99▼
Germany
91▼
Brazil
89▼
Netherlands
65▼
Canada
62▼
United Kingdom
62▼

Rare Disease Focus Areas (63)

Diseases targeted by Roche Holding AG / Genentech's clinical trial and drug development programs

Adrenocortical CarcinomaRare Cancers

Adrenocortical carcinoma is a rare, aggressive cancer of the adrenal cortex, the outer layer of the adrenal glands that sit on top of each kidney. These glands produce essential hormones including cor...

Prevalence: About 1-2 per million people per year; approximately 600 new cases per year in the U.S.
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
Atypical Hemolytic Uremic SyndromeKidney & Renal

Atypical Hemolytic Uremic Syndrome (aHUS) is a rare kidney disease caused by uncontrolled activation of the complement system, a part of the immune system that normally helps fight infection. This act...

Prevalence: Approximately 1-2 cases per million people per year; rare form of HUS accounting for 5-10% of all HUS cases
Autoimmune HepatitisGastrointestinal

Autoimmune Hepatitis (AIH) is a chronic liver disease characterized by persistent inflammation and progressive fibrosis of the liver due to loss of immune tolerance to hepatocyte antigens. The immune ...

Prevalence: Approximately 0.1 to 1.9 per 100,000 people globally depending on region; accounts for 10-20% of chronic hepatitis cases
Bullous PemphigoidDermatologic

Bullous pemphigoid is an autoimmune blistering disorder caused by autoantibodies against basement membrane proteins, particularly BP180 and BP230. The condition leads to formation of large fluid-fille...

Prevalence: Approximately 2-23 per million people per year; incidence increases sharply with age

Patient Resources

Organizations and resources related to Roche Holding AG / Genentech's rare disease focus areas

Frequently Asked Questions About Roche Holding AG / Genentech

Common questions about Roche Holding AG / Genentech's rare disease programs, clinical trials, and treatments.