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  1. pharmadog
  2. ›drugs
  3. ›Zilbrysq
drug
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zilucoplan

Marketedupdated 3mo ago
by UCB SA
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval24 co-mentions · 6 sources
  • drugZILBRYSQ24 co-mentions · 6 sources

all catalysts(6)

approval · 6
Oct 17, 2023
approval
3y ago
ZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approval
zilucoplan
→
Jan 16, 2024
approval
3y ago
ZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approval
zilucoplan
→
Apr 26, 2024
approval
2y ago
ZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approval
zilucoplan
→
Feb 28, 2025
approval
1y ago
ZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approval
zilucoplan
→
Feb 28, 2025
approval
1y ago
ZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approval
zilucoplan
→
Jan 22, 2026
approval
7mo ago
ZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approval
zilucoplan
→

Trials studying zilucoplan

  • phase3A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravisrecruitingn=8
  • phase3Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravisactive not recruitingn=200
  • phase3An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravisenrolling by invitationn=8
  • phase3A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Graviscompletedn=31
  • phase1A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Womenrecruitingn=15
  • phase3Zilucoplan for Severe gMG Exacerbationsrecruitingn=15
  • phase1A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participantscompletedn=14
  • phase3An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitorscompletedn=26
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 17, 2028
~2.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (27)

  • Jun 12, 2035compositionUS 10106579
  • Jun 12, 2035compositionUS 10106579
  • Jun 12, 2035compositionUS 10106579
  • Jun 12, 2035compositionUS 10208089
  • Jun 12, 2035compositionUS 10208089
  • Jun 12, 2035compositionUS 10208089
  • Jun 12, 2035compositionUS 10435438
  • Jun 12, 2035compositionUS 10435438
  • Jun 12, 2035compositionUS 10435438
  • Jun 12, 2035compositionUS 10562934
  • Jun 12, 2035compositionUS 10562934
  • Jun 12, 2035compositionUS 10562934
  • Jun 12, 2035formulationUS 10835574
  • Jun 12, 2035formulationUS 10835574
  • Jun 12, 2035formulationUS 10835574
  • Jun 12, 2035compositionUS 11014965
  • Jun 12, 2035compositionUS 11014965
  • Jun 12, 2035compositionUS 11014965
  • Jun 12, 2035formulationUS 11535650
  • Jun 12, 2035formulationUS 11535650
  • Jun 12, 2035formulationUS 11535650
  • Jun 12, 2035formulationUS 11752190
  • Jun 12, 2035formulationUS 11752190
  • Jun 12, 2035formulationUS 11752190
  • Jun 12, 2035formulationUS 11965040
  • Jun 12, 2035formulationUS 11965040
  • Jun 12, 2035formulationUS 11965040

FDA exclusivities (6)

  • Oct 17, 2030ODE-446Orphan Drug (7y)4.2y
  • Oct 17, 2030ODE-446Orphan Drug (7y)4.2y
  • Oct 17, 2030ODE-446Orphan Drug (7y)4.2y
  • Oct 17, 2028NCENew Chemical Entity (5y)2.2y
  • Oct 17, 2028NCENew Chemical Entity (5y)2.2y
  • Oct 17, 2028NCENew Chemical Entity (5y)2.2y

News(0)

no news has mentioned this drug yet

brand
Zilbrysq
generic
zilucoplan
indication
Myasthenia Gravis
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 21m ago
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