Apellis Pharmaceuticals

Apellis Pharmaceuticals works on 10 rare diseases tracked on Trial Friend, including Amyotrophic Lateral Sclerosis, C3 Glomerulopathy, Cold Agglutinin Disease and 7 more, with 6 recruiting clinical trials and 2 FDA-approved rare disease drugs.

Apellis Pharmaceuticals develops targeted C3 complement inhibitors for hematologic and renal rare diseases. EMPAVELI (pegcetacoplan) is FDA-approved for paroxysmal nocturnal hemoglobinuria (2021) and for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis (July 2025). SYFOVRE is approved for geographic atrophy. In May 2026, Biogen completed its acquisition of Apellis for approximately $5.6 billion in upfront equity plus a contingent value right; Apellis is now a wholly owned subsidiary of Biogen.

Type
Rare Disease Specialist
Parent
Biogen
Headquarters
Waltham, United States
Founded
2009
6
Active Rare Disease Trials
2
Approved Rare Disease Drugs
10
Rare Diseases in Portfolio
17
Years Active

Apellis Pharmaceuticals Drug Pipeline

Apellis Pharmaceuticals has 6 active clinical trials across 3 development stages, with 6 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 Apellis 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 Apellis Pharmaceuticals's pipeline
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2
Phase 22 trials
2
Phase 32 trials
Recruiting
C3G+4 more
Recruiting
2
Other2 trials

Apellis Pharmaceuticals Clinical Trials (6)

Active and recruiting clinical trials sponsored by Apellis 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.

Ask about Apellis Pharmaceuticals's trials
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RECRUITINGPHASE2, PHASE3Recently updatedNCT07213960

A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis

Intervention: APL2, Placebo

This is a sequential phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.

Ages 18 Years+2 locations
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RECRUITINGPHASE2Updated a few months agoNCT04901936

A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Intervention: Pegcetacoplan

The purpose of this study is to evaluate the safety, effectiveness, and biological activity (how the investigational medication is processed by the body) of pegcetacoplan in 12-17 year-olds (adolescents) who have paroxysmal nocturnal hemoglobinuria (PNH).

Ages 12 Years - 17 Years12 locations
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RECRUITINGPHASE2Updated a few months agoNCT07215390

A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio

Intervention: APL-3007, pegcetacoplan (APL-2), APL-3007, pegcetacoplan (APL-2), Placebo, Syfovre

A Phase 2, Randomized, Placebo-controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL-3007 in Combination with Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Ages 60 Years+78 locations
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RECRUITINGUpdated a few months agoNCT07582042

Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA).

The goal of this observational study is to evaluate changes in retinal sensitivity over time in patients with geographic atrophy due to age related macular degeneration who are receiving pegcetacoplan as part of routine clinical care. The study aims to determine whether lesion tailored fundus-controlled perimetry can reliably measure functional changes near areas of atrophy and whether this testing can be implemented in everyday clinic care over 24 months. Participants will undergo repeated vision testing, standard eye imaging, and visual function questionnaires while continuing their prescribed treatment.

Ages 65 Years - 90 Years1 location
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ACTIVE NOT RECRUITINGUpdated a few months agoNCT06161584

A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Intervention: Pegcetacoplan

A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Ages 60 Years+34 locations
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ACTIVE NOT RECRUITINGPHASE3Updated a few months agoNCT05809531

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

Intervention: Pegcetacoplan

C3GIC-MPGNC3 GlomerulopathyC3 GlomerulonephritisComplement 3 Glomerulopathy

This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

Ages 12 Years+47 locations
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Apellis Pharmaceuticals FDA-Approved Drugs (2)

Medications developed or marketed by Apellis 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
PEGCETACOPLAN
Complement Inhibitor [EPC]
Empaveli
subcutaneous
May 14, 2021
PEGCETACOPLAN
Complement Inhibitor [EPC]
Syfovre
intravitreal
Feb 17, 2023

Apellis Pharmaceuticals Trial Locations

Apellis Pharmaceuticals clinical trials are running at 174 sites in 18 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
128▼
Brazil
9▼
Netherlands
5▼
Spain
5▼
United Kingdom
4▼
France
3▼
Italy
3▼
Czechia
2▼
Thailand
2▼
Argentina
2▼
Australia
2▼
Japan
2▼

Rare Disease Focus Areas (10)

Diseases targeted by Apellis 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
C3 GlomerulopathyKidney & Renal

C3 glomerulopathy is a group of rare kidney diseases caused by dysregulation of the alternative complement pathway, leading to uncontrolled C3 deposition in the glomeruli. The two subtypes, C3 glomeru...

Prevalence: 1 to 2 new cases per million per year; approximately 5,000 to 10,000 affected individuals in the U.S.
Cold Agglutinin DiseaseBlood & Immune

Cold agglutinin disease is a rare autoimmune hemolytic anemia caused by IgM autoantibodies that bind red blood cells in cold temperatures. The condition leads to intravascular hemolysis particularly i...

Prevalence: Estimated at 1 in 300,000 to 1,000,000 people
Focal Segmental GlomerulosclerosisKidney & Renal

Focal Segmental Glomerulosclerosis (FSGS) is a kidney disease characterized by scarring of some glomeruli, the tiny filtering units that remove waste from the blood. The disease can develop on its own...

Prevalence: Approximately 7% of all kidney biopsies in the United States show FSGS; incidence is 0.2-1.7 cases per 100,000 person-years
Geographic AtrophyEye & Vision

Geographic atrophy is the advanced form of dry age-related macular degeneration, characterized by progressive loss of retinal pigment epithelium, photoreceptors, and choriocapillaris in well-defined a...

Prevalence: Approximately 1 million people in the U.S.; affects about 20% of those with age-related macular degeneration
IgA NephropathyKidney & Renal

IgA nephropathy is the most common primary glomerulonephritis worldwide, caused by abnormal IgA1 antibodies depositing in the kidney's mesangium, activating complement pathways and triggering inflamma...

Prevalence: Incidence is about 1 in 100,000 people per year in the U.S. (IgA Nephropathy Foundation); cumulative U.S. prevalence is estimated at roughly 130,000 to 150,000 cases. Significantly more common in East Asian and Pacific Islander populations, with reported incidence up to 4 times higher.

Patient Resources

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

Frequently Asked Questions About Apellis Pharmaceuticals

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