Orladeyo

(Berotralstat)

Phase 3Small molecule

BBioCryst Pharmaceuticals

Orladeyo is one of 30 small molecule programs targeting Hereditary Angioedema. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Hereditary AngioedemaActive, not recruiting

Hereditary AngioedemaPhase 3

Active, not recruiting

Competition

Competitive Landscape

43 competitors in Hereditary Angioedema

#DrugCompanyPhaseTrials

Neoral

Crestor

Firazyr

5 4

Lanoxin

Andembry

1 6

Cyklokapron

AAmring

Phase 3

1 7

KALBITOR

Takeda

Phase 3

5 8

C1 Esterase Inhibitor

Takeda

Phase 3

8 9

Dawnzera (autoinjector)

Ionis Pharmaceuticals

Phase 3

6 10

Ruconest

PPharming Technologies B.V.

Approved

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]

Oral1 trial

Oral Berotralstat Expanded Access Program

Approved for marketing·BBioCryst Pharmaceuticals··NCT04428632

HAE1 trial

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

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

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

Orladeyo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Oral1 trial

HAE1 trial

Hereditary Angioedema1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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