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Apellis Pharmaceuticals Inc (APLS)
NASDAQ:APLS
Apl-2, Pegcetacoplan
Geographic Atrophy Secondary To Age-Related Macular Degeneration
Phase III
Not Yet Recruiting
Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe
Oct 06, 2025
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Apl2
Fsgs
Phase II/III
Not Yet Recruiting
A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis
Sep 15, 2025
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Apl-3007, Pegcetacoplan (Apl-2)
Geographic Atrophy Secondary To Age-Related Macular Degeneration
Phase II
Recruiting
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
Jun 30, 2025
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Pegcetacoplan
End Stage Renal Disease, Delayed Graft Function, Deceased Donor Kidney Transplant
Phase III
Not Yet Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation
Jun 06, 2025
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Pegcetacoplan
C3 Glomerulonephritis, Dense Deposit Disease, C3 Glomerulopathy, Complement 3 Glomerulopathy, C3g, Ic-Mpgn, Complement 3 Glomerulopathy (C3g), Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (Mpgn), Immune Complex Membranoproliferative Glomerulonephritis (Ic-Mpgn), Complement 3 Glomerulonephritis, Ddd
Phase III
Active Not Recruiting
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
Mar 30, 2023
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Pegcetacoplan
Transplant-Associated Thrombotic Microangiopathy
Phase II
Completed
Evaluate the PK Efficacy Safety and Tolerability of Pegcetacoplan in Patients With Thrombotic Microangiopathy
Oct 21, 2021
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Pegcetacoplan
C3 Glomerulonephritis, Dense Deposit Disease, C3 Glomerulopathy, Complement 3 Glomerulopathy, C3g, Ic-Mpgn, Complement 3 Glomerulopathy (C3g), Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (Mpgn), Immune Complex Membranoproliferative Glomerulonephritis (Ic-Mpgn), Complement 3 Glomerulonephritis, Ddd
Phase III
Completed
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
Sep 23, 2021
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Pegcetacoplan
Paroxysmal Nocturnal Hemoglobinuria (Pnh), Paroxysmal Hemoglobinuria
Phase II
Recruiting
A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Mar 08, 2021
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Pegcetacoplan (Apl-2)
Geographic Atrophy Secondary To Age-Related Macular Degeneration
Phase III
Completed
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
Feb 23, 2021
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Pegcetacoplan
C3 Glomerulonephritis, C3 Glomerulopathy, Complement 3 Glomerulopathy, C3g, Ic-Mpgn, Renal Transplant, Complement 3 Glomerulopathy (C3g), Dense Deposit Disease (Ddd), Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (Mpgn), Immune Complex Membranoproliferative Glomerulonephritis (Ic-Mpgn), Complement 3 Glomerulonephritis
Phase II
Active Not Recruiting
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
Sep 29, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Apellis Pharmaceuticals Inc (APLS) have in its pipeline
APLS is currently developing the following drugs: Apl-2, Pegcetacoplan, Apl2, Apl-3007, Pegcetacoplan (Apl-2). These drug candidates are in various stages of clinical development as the company works toward FDA approval.