SYFOVRE (pegcetacoplan)
Syfovre treats geographic atrophy, a condition that develops in patients with age-related macular degeneration. This medication helps patients with this advanced form of eye disease by functioning as a complement inhibitor. It is used to address the specific biological pathways that contribute to the progression of retinal damage.
How SYFOVRE Works
This medication works by binding with high affinity to the complement protein C3 and its activation fragment, C3b. This binding regulates the cleavage of C3 and the subsequent generation of downstream effectors of complement activation. By controlling these specific immune proteins, the drug helps manage the biological activity associated with the condition.
Details
- Status
- Prescription
- First Approved
- 2023-02-17
- Patent Cliff
- 2038
- Routes
- INTRAVITREAL
- Dosage Forms
- SOLUTION
SYFOVRE Approval History
What SYFOVRE Treats
2 indicationsSYFOVRE is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Geographic Atrophy
- Age-Related Macular Degeneration
SYFOVRE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SYFOVRE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07214298 | I-4316824 NCI-2025-06680, I-4316824 | Ph 1, Ph 2 | recruiting | Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma |
| NCT04572854 NOBLE results posted | APL2-C3G-204 | Ph 2 | completed | Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN |
| NCT03531255 | APL2-307 | Ph 3 | active not recruiting | Pegcetacoplan Long Term Safety and Efficacy Extension Study |
| NCT05809531 VALE | APL2-C3G-314 2023-504625-39-00, U1111-1290-7826 | Ph 3 | 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 |
| NCT04919629 | I 798120 NCI-2021-04265, I 798120 | Ph 2 | recruiting | APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion |
| NCT07020832 | APL2-DGF-318 | Ph 3 | 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 |
| NCT07160179 | M24-204 | Ph 1, Ph 2 | recruiting | Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration |
| NCT06722157 VERDANT | 1497-0002 U1111-1308-7923 | Ph 2 | active not recruiting | A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy |
| NCT05067127 VALIANT results posted | APL2-C3G-310 | Ph 3 | completed | Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis |
| NCT05148299 results posted | Sobi.PEGCET-201 2023-510443-37-00, 2021-003157-27 | Ph 2 | completed | A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation |
| NCT05096403 results posted | Sobi.PEGCET-101 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD) |
| NCT04901936 | APL2-PNH-209 | Ph 2 | recruiting | A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| NCT03500549 results posted | APL2-302 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| NCT02588833 PADDOCK results posted | APL2-CP-PNH-204 | Ph 1 | completed | Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects. |
| NCT02264639 results posted | APL-CP0514 | Ph 1 | completed | A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH |
| NCT03593200 results posted | APL2-202 | Ph 2 | completed | A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With PNH |
| NCT02503332 FILLY results posted | POT-CP121614 | Ph 2 | completed | Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy |
| NCT02461771 ASAP II results posted | POT-CP043014 | Ph 1 | completed | Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD |
| NCT03465709 results posted | APL2-203 | Ph 1, Ph 2 | terminated | Pegcetacoplan (APL-2) in Neovascular AMD |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SYFOVRE FDA Label Details
Indications & Usage
FDA Label (PDF)SYFOVRE is indicated for the treatment of Geographic Atrophy; Age-Related Macular Degeneration.
SYFOVRE Patents & Exclusivity
Patents (13 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SYFOVRE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 16 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.