Regeneron Pharmaceuticals

Regeneron Pharmaceuticals works on 23 rare diseases tracked on Trial Friend, including Amyotrophic Lateral Sclerosis, Aplastic Anemia, ATTR Amyloidosis (Transthyretin Amyloidosis) and 20 more, with 16 recruiting clinical trials and 7 FDA-approved rare disease drugs.

Regeneron Pharmaceuticals develops therapeutic candidates to treat rare diseases including rare autoinflammatory conditions. The company applies its monoclonal antibody technology and other platforms to address rare eye diseases, allergic and inflammatory conditions, and other rare genetic disorders.

Type
Diversified Pharma
Ticker
REGN
Headquarters
Tarrytown, United States
Founded
1988
16
Active Rare Disease Trials
7
Approved Rare Disease Drugs
23
Rare Diseases in Portfolio
38
Years Active

Focus areas at Regeneron Pharmaceuticals

Within its broader pharmaceutical portfolio, Regeneron Pharmaceuticals has active clinical trial programs and drug development efforts across 23 rare diseases, including Amyotrophic Lateral Sclerosis, Aplastic Anemia, ATTR Amyloidosis (Transthyretin Amyloidosis), Bullous Pemphigoid, Diffuse Intrinsic Pontine Glioma, and 18 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 Regeneron Pharmaceuticals, 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.

Regeneron Pharmaceuticals is headquartered in Tarrytown, United States, founded in 1988, publicly traded under the ticker symbol REGN. 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.

Regeneron Pharmaceuticals Drug Pipeline

Regeneron Pharmaceuticals has 16 active clinical trials across 3 development stages, with 16 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 Regeneron Pharmaceuticals'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 Regeneron Pharmaceuticals's pipeline
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9
Phase 29 trials
Juvenile Idiopathic Arthritis
Recruiting
B-cell Non-Hodgkin Lymphoma (B-NHL)
Recruiting
6
Phase 36 trials
1
Phase 4 / Post-Market1 trial
Recruiting

Regeneron Pharmaceuticals Clinical Trials (16)

Active and recruiting clinical trials sponsored by Regeneron Pharmaceuticals, 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.

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RECRUITINGPHASE3Recently updatedNCT07112378

A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis

Intervention: dupilumab

This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment. The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Ages 6 Months - 6 Years13 locations
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RECRUITINGPHASE3Recently updatedNCT05744921

A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works

Intervention: Pozelimab, Cemdisiran

This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as "study drugs" in this section. This study is looking at several other research questions, including: * How effective is the pozelimab + cemdisiran combination? * What side effects may happen from taking the study drugs? * How much of each study drug is in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)

Ages 18 Years+48 locations
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RECRUITINGPHASE2Recently updatedNCT07318597

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

Intervention: REGN13335, Placebo

This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines. The study is looking at several other research questions, including: * What side effects may happen from taking REGN13335 * How much REGN13335 is in the blood at different times * Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)

Ages 18 Years+32 locations
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RECRUITINGPHASE2Recently updatedNCT02991469

A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)

Intervention: Sarilumab SAR153191 (REGN88)

Juvenile Idiopathic Arthritis

Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population. Secondary Objective: To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.

Ages 1 Year - 17 Years37 locations
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RECRUITINGPHASE3Recently updatedNCT06541704

A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy

Intervention: Pozelimab, Cemdisiran, Placebo

Age-related Macular Degeneration (AMD)Geographic Atrophy (GA)

This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Ages 50 Years - 85 Years225 locations
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RECRUITINGPHASE1, PHASE2Recently updatedNCT06292780

A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)

Intervention: Linvoseltamab

This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): * In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. * In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long * How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long * What the right dosing regimen is for linvoseltamab * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)

Ages 18 Years+21 locations
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RECRUITINGPHASE2Recently updatedNCT07234058

Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma

Intervention: Cemiplimab, Fianlimab, Pemetrexed (Alimta), Cisplatin, Carboplatin (AUC 5)

This is a multicentre, phase IIR, double non-comparative arm trial, with an initial safety run for the anti-LAG3 arm. Approximately 40 sites will participate in the study and will enroll 126 patients with treatment-naive, unresectable malignant PM. Treatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent or for 2 years immunotherapy maximum. Once the patient discontinues study treatment, the treatment period will end and the patient will enter the follow-up period. No cross-over is allowed between arms.

Ages 18 Years - 75 Years37 locations
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Regeneron Pharmaceuticals FDA-Approved Drugs (7)

Medications developed or marketed by Regeneron Pharmaceuticals 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
AFLIBERCEPT
Vascular Endothelial Growth Factor Inhibitor [EPC]
EYLEA HD
intravitreal
Aug 18, 2023
ATOLTIVIMAB, MAFTIVIMAB, AND ODESIVIMAB-EBGNInmazeb
intravenous
Oct 14, 2020
CEMIPLIMAB-RWLCLIBTAYO
intravenous
Sep 28, 2018
GARETOSMAB-GRTSPasatru
intravenous
Aug 19, 2026
ALIROCUMAB
PCSK9 Inhibitor [EPC]
Praluent
subcutaneous
Jul 24, 2015

Regeneron Pharmaceuticals Trial Locations

Regeneron Pharmaceuticals clinical trials are running at 796 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
233▼
France
69▼
Spain
55▼
South Korea
43▼
Germany
43▼
Italy
35▼
United Kingdom
35▼
Taiwan
28▼
Australia
26▼
Japan
25▼
India
20▼
Poland
20▼

Rare Disease Focus Areas (23)

Diseases targeted by Regeneron Pharmaceuticals's clinical trial and drug development programs

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
Aplastic AnemiaBlood & Immune

Aplastic anemia is a rare bone marrow failure syndrome characterized by pancytopenia resulting from absent or severely reduced hematopoiesis. Approximately half are immune-mediated, while others resul...

Prevalence: 1-2 cases per 1 million people per year
ATTR Amyloidosis (Transthyretin Amyloidosis)Metabolic & Lysosomal

ATTR amyloidosis is a rare progressive disease where abnormal transthyretin protein accumulates as amyloid deposits in the heart, nerves, and other organs. It can be inherited (hereditary ATTR) or dev...

Prevalence: Approximately 5,000 to 7,000 new cases diagnosed annually in the U.S.
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
Diffuse Intrinsic Pontine GliomaRare Cancers

Diffuse intrinsic pontine glioma (DIPG) is an aggressive childhood brain tumor that grows in the pons, the part of the brainstem controlling breathing, swallowing, and movement. Because it weaves thro...

Prevalence: About 300 children diagnosed in the U.S. each year, most often between ages 5 and 10
Eosinophilic EsophagitisGastrointestinal

Eosinophilic Esophagitis is a rare allergic/immune-mediated inflammatory disease of the esophagus characterized by eosinophil infiltration causing progressive narrowing and dysfunction. It presents wi...

Prevalence: Approximately 50-140 cases per 100,000 people (increasing incidence); estimated prevalence 1 in 2,000 to 1 in 400 in developed countries

Patient Resources

Organizations and resources related to Regeneron Pharmaceuticals's rare disease focus areas

Frequently Asked Questions About Regeneron Pharmaceuticals

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