Is Pegcetacoplan legal?
Written by Aaron CuhaReviewed Sep 2026
- US: FDA-approved, prescription only
- UK: Licensed for the blood disease only
- AU: Registered for the blood disease only
- CA: Approved for the blood disease only
The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.
All four countries, side by side
| What we list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Approved | Approved | Approved |
| Legal category | FDA-approved, prescription only | Licensed for the blood disease only | Registered for the blood disease only | Approved for the blood disease only |
| Note | Two separate approvals, for separate diseases, given in separate ways. Empaveli, NDA 215014, was approved 14 May 2021 as a drip under the skin for paroxysmal nocturnal haemoglobinuria, and later for C3 glomerulopathy. Syfovre, NDA 217171, was approved 17 February 2023 as a shot into the eye for geographic atrophy. | The whole-body product is approved in Europe for paroxysmal nocturnal haemoglobinuria. The eye shot for geographic atrophy was refused. The European Medicines Agency committee voted against it in June 2024 and upheld that on a second look in September 2024. Its reason: slowing the growth of the damaged patches did not give patients a benefit that mattered to them. | The eye product for geographic atrophy is not available the way it is in the United States. Prescription only, for specialists. | Prescription only, for specialists. It is used by blood doctors, not eye doctors. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: FDA-approved twice. Empaveli (NDA 215014) was approved 14 May 2021 as a drip under the skin. It is for adults with paroxysmal nocturnal haemoglobinuria, a rare disease where the immune system destroys red blood cells. It is now also approved from age 12 for two rare kidney diseases, C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis. Syfovre (NDA 217171) was approved 17 February 2023 as a shot into the eye. It is for geographic atrophy, a late stage of age-related macular degeneration. The European Medicines Agency refused the geographic atrophy use in 2024.. Reviewed Sep 2026.
Country by country
Is Pegcetacoplan legal in the United States?
Yes. Pegcetacoplan is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full United States answerIs Pegcetacoplan legal in the United Kingdom?
Yes. Pegcetacoplan is an approved medicine in the United Kingdom. Its legal category is "Licensed for the blood disease only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full United Kingdom answerIs Pegcetacoplan legal in Australia?
Yes. Pegcetacoplan is an approved medicine in Australia. Its legal category is "Registered for the blood disease only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full Australia answerIs Pegcetacoplan legal in Canada?
Yes. Pegcetacoplan is an approved medicine in Canada. Its legal category is "Approved for the blood disease only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full Canada answerPegcetacoplan in sport and the military
Whether Pegcetacoplan is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. Before you compete or get tested, look up Pegcetacoplan by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
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General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.