macrocyclic peptide complement inhibitor
Zilucoplan
Answer
Zilucoplan is authorised or registered in the US, the EU, the UK, Canada, Australia, Switzerland and Turkey: 7 of the 10 registers read. Highest trial phase: Phase 3 (4 phase 3 trials, 0 with posted results). It has 24 registered trials, 6 of them running. Brand names on the FDA label register: Zilbrysq.
RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03
Not medical, legal or regulatory advice.
24 trials by status
Trial registerClinicalTrials.gov and EU CTIS · read 2026-10-03 · 12 trials have posted results
Trials first submitted per year
Trial registerClinicalTrials.gov first-submitted date, last 7 years · read 2026-10-03. 5 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).
Status by jurisdiction
World map| Where | Status | Register | Read |
|---|---|---|---|
| United States | FDA-approved | FDA, openfda | 2026-10-03 |
| European Union | Authorised | EMA, ema | 2026-10-03 |
| United Kingdom | Authorised | MHRA, uk-mhra | 2026-10-03 |
| Canada | Authorised | Health Canada, ca-dpd | 2026-10-03 |
| Australia | Registered | TGA, au-artg | 2026-10-03 |
| Switzerland | Authorised | Swissmedic, ch-swissmedic | 2026-10-03 |
| Brazil | Not on the register | ANVISA, br-anvisa | 2026-09-03 |
| Serbia | Not on the register | ALIMS, rs-alims | 2026-09-03 |
| Singapore | Not on the register | HSA, sg-hsa | 2026-09-03 |
| Turkey | Ruhsatli | TITCK, tr-titck | 2026-09-03 |
An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.
Side effects
Trial registerCHANGE ALERTS
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One email when the status of Zilucoplan changes on the register. You confirm your address first.
REGISTERED TRIALS
Newest 10 of 24 trials
| NCT06055959 | A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis currently recruiting participants · register updated 2026-10-02 |
|---|---|
| NCT06435312 | An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis enrolling by invitation only · register updated 2026-10-02 |
| NCT07215949 | Zilucoplan for Severe gMG Exacerbations currently recruiting participants · register updated 2026-08-28 |
| NCT06961747 | A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women currently recruiting participants · register updated 2026-08-27 |
| NCT04225871 | Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis completed · register updated 2026-08-12 |
| NCT04297683 | HEALEY ALS Platform Trial - Master Protocol running, but no longer enrolling · register updated 2026-07-21 |
| 2022-502072-23-00 | A MULTICENTER OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY, TOLERABILITY, AND ACTIVIT no status recorded · register updated 2026-06-05 |
| 2022-502073-42-00 | AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ACTIVITY OF no status recorded · register updated 2026-06-05 |
| NCT06471361 | A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gra completed · register updated 2026-03-27 |
| NCT06511076 | A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Particip completed · register updated 2026-01-06 |
WEEKLY
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New trials, approvals and enforcement actions. One email a week.