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Orladeyo

(Berotralstat)

Phase 3Small molecule

BBioCryst Pharmaceuticals

Orladeyo is one of 13 small molecule programs targeting HAE. It is currently in Phase 3.

2

Indications

3

Total Trials

2

Active Trials

12

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

32

Patents

Pipeline

Status by Indication[3][1]

Indication

HAEEnrolling by invitation

Hereditary AngioedemaActive, not recruiting

HAEPhase 3

Enrolling by invitation

Hereditary AngioedemaPhase 3

Active, not recruiting

Competition

Competitive Landscape

13 competitors in Hereditary Angioedema

#DrugCompanyPhaseTrials

Crestor

Neoral

Lanoxin

Andembry

Dawnzera (autoinjector)

Ionis Pharmaceuticals

Orladeyo

BBioCryst Pharmaceuticals

Deucrictibant

PPharvaris Netherlands B.V.

KVD900

KKalVista Pharmaceuticals, Ltd.

ADX-324

AADARx Pharmaceuticals, Inc.

Heparin Sodium

BBaxter Healthcare Corporation

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Hereditary Angioedema

NCT05453968

Clinical

Trials by Indication[1]

HAE1 trial

Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

Enrolling by invitation·BBioCryst Pharmaceuticals·Phase 3·NCT04933721·139 enrolled

Oral1 trial

Oral Berotralstat Expanded Access Program

Approved for marketing·BBioCryst Pharmaceuticals··NCT04428632

Hereditary Angioedema1 trial

Berotralstat Treatment in Children With Hereditary Angioedema

Active, not recruiting·BBioCryst Pharmaceuticals·Phase 3·NCT05453968·29 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 3, 2020

ORLADEYO

NDA NDA214094

Dec 11, 2025

ORLADEYO

NDA NDA219776

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Berotralstat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Berotralstat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Berotralstat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219776). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Orladeyo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — BioCryst Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBioCryst Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Mar 9, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11230530Mar 9, 2035

10329260Mar 9, 2035

12116346Mar 9, 2035

10689346Mar 9, 2035

11708333Mar 9, 2035

27 more patents

10125102Apr 7, 2035

11708333*PEDSep 9, 2035

11230530*PEDSep 9, 2035

10329260*PEDSep 9, 2035

10689346*PEDSep 9, 2035

12116346*PEDSep 9, 2035

10125102*PEDOct 7, 2035

11117867Nov 1, 2039

12344585Nov 1, 2039

10662160Nov 1, 2039

11618733Nov 1, 2039

12552750Nov 1, 2039

12545646Nov 1, 2039

12545645Nov 1, 2039

12545647Nov 1, 2039

12590068Nov 1, 2039

12590069Nov 1, 2039

10662160*PEDMay 1, 2040

12344585*PEDMay 1, 2040

12545646*PEDMay 1, 2040

12545645*PEDMay 1, 2040

12590069*PEDMay 1, 2040

12590068*PEDMay 1, 2040

12552750*PEDMay 1, 2040

12545647*PEDMay 1, 2040

11117867*PEDMay 1, 2040

11618733*PEDMay 1, 2040

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