Orladeyo

What Orladeyo does

Orladeyo is the consumer-facing product brand for ORLADEYO (berotralstat), a prescription oral preventative medication developed and marketed by BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) for the prevention of hereditary angioedema (HAE) attacks in adults and children aged 2 and older. The active ingredient is a small-molecule kallikrein inhibitor that blocks the overactive kallikrein protein driving the swelling attacks characteristic of HAE, positioning Orladeyo as the first and only targeted oral preventative therapy in this indication.

The product is offered in two age-tailored formulations: 150 mg capsules taken once daily with food for patients 12 years and older, and oral pellets (weight-based dosing) for children 2 to less than 12 years that can be taken directly with non-acidic liquid or sprinkled on soft food. Commercialization is supported by Empower Patient Services, a BioCryst-operated specialty pharmacy providing a 24/7 clinical team (pharmacists and nurses), insurance navigation, monthly refill coordination, and a digital patient portal for adherence and refill management. Pediatric education is reinforced through Olly™, an animated mascot used across patient-facing materials.

Revenue is generated through US prescription sales routed exclusively through Empower Patient Services; pricing is not publicly disclosed but a copay-assistance program enables eligible commercially insured patients to pay as little as $0 per fill. More than 3,500 individuals have been prescribed Orladeyo, with reported clinical outcomes including a 91% reduction in monthly attack frequency at two years, an 88% reduction in rescue medication use, 96% symptom-free days in pediatric patients at one year, and 98% attack-free continuity in patients switching from injectable therapy. Marketing spans a patient-facing website, a separate HCP portal, social community engagement under #OrladeyoCommunity, events, and email programs.

Name

Orladeyo

Legal name

BioCryst Pharmaceuticals, Inc.

Website

https://orladeyo.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

Orladeyo (berotralstat) is BioCryst Pharmaceuticals' prescription oral preventative for hereditary angioedema attacks. Marketed in capsule form for ages 12+ and oral pellets for ages 2-12, the once-daily kallikrein inhibitor is supported by the Empower Patient Services specialty pharmacy in the US.

Ownership category

akta.pro rank

Product category

Prescription Pharmaceuticals

SIC

Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Urticaria/Angioedema (Hives) Specialty Care (HLAKAAAG)

Keywords

• Hereditary angioedema treatment
• Oral HAE prevention
• Kallikrein inhibitor therapy
• Specialty pharmaceutical drug
• Rare disease medication

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Technology or R&D, Marketing or Sales, Personnel, Operations

Revenue model

1. Prescription Pharmaceutical Sales: Prescription medication distributed through specialty pharmacy (Empower Patient Services). Revenue generated through insurance reimbursement, patient copay assistance, and direct pharmaceutical sales. Treatment for hereditary angioedema (HAE) in adults and children 2 years and older.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels8 records

Core offering

Orladeyo (berotralstat) is a prescription oral preventative treatment for hereditary angioedema (HAE) attacks, available as 150 mg capsules for adults and adolescents aged 12 and older and as oral pellets for children aged 2 to less than 12 (weight-based dosing). The active ingredient, berotralstat, is a small molecule that blocks the kallikrein protein to prevent HAE swelling attacks before they occur. The product is supported by Empower Patient Services, a specialty pharmacy and patient support program providing 24/7 clinical access, insurance navigation, and refill coordination.

Product overview

ORLADEYO (berotralstat) is a prescription oral preventative treatment for hereditary angioedema (HAE). The product portfolio consists of two formulations: 150 mg capsules for patients 12 years and older, and oral pellets for children ages 2 to less than 12 years (weight-based dosing). Both formulations are taken once daily with food and work by targeting the kallikrein protein to prevent HAE attacks before they occur. The offering is supported by Empower Patient Services, a specialty pharmacy and support program that includes a 24/7 clinical team, insurance navigation, refill coordination, and a digital patient portal for treatment management. Patient education is enhanced through Olly™, an animated mascot character designed to help pediatric patients understand and take their medication.

Differentiator

Problem solved

Functional benefit

Products and services

• ORLADEYO (berotralstat) 150 mg capsules Prescription oral capsule for adults and adolescents 12 years and older, taken once daily with food to prevent hereditary angioedema attacks by blocking the kallikrein protein.
• ORLADEYO (berotralstat) oral pellets Prescription oral pellet formulation of berotralstat for children aged 2 to less than 12 years old, dosed by weight and taken directly in the mouth with non-acidic liquid or sprinkled on soft food to prevent HAE attacks.
• Empower Patient Services Dedicated specialty pharmacy and patient support program for ORLADEYO patients, providing insurance navigation, prescription coordination, monthly refill management, and 24/7 access to pharmacists and nurses.

Quantifiable outcome

• 91% reduction in attacks per month after 2 years of treatment
• +7 more outcomes

Named customers8 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators7 records

Recent moves4 records

Expansion highlights4 records

Emerging players

• Ionis Pharmaceuticals: Developing donidalorsen, an antisense oligonucleotide for HAE prophylaxis. Represents an emerging alternative preventative approach using RNA-targeting technology in the same HAE market.
• Pharvaris: Clinical-stage company developing deucricitibant, an oral bradykinin B2 receptor antagonist for both acute and preventive HAE treatment. Emerging oral competitor that could challenge Orladeyo's oral-prevention positioning if approved.
• KalVista Pharmaceuticals: Developing sebetralstat, an oral on-demand HAE treatment. While currently focused on acute attacks, the oral platform represents a potential future oral preventative competitor in the HAE space.

Direct peers

• Pharming Group (Ruconest): Markets Ruconest, a recombinant C1-esterase inhibitor for acute HAE attacks. Smaller HAE-focused competitor operating in the same therapeutic area with overlapping patient population.
• CSL Behring (Haegarda): Markets Haegarda, a subcutaneous C1-esterase inhibitor for HAE prophylaxis. Targets the same hereditary angioedema prevention indication as Orladeyo with a plasma-derived protein alternative.
• Takeda Pharmaceutical (Takhzyro): Direct competitor in HAE prevention with Takhzyro (lanadelumab), a subcutaneous injectable kallikrein inhibitor. Competes head-to-head with Orladeyo in the same HAE prophylactic market but uses an injectable route of administration.

Broad incumbents

• Swedish Orphan Biovitrum (Sobi): Specialty rare-disease biopharmaceutical company with HAE franchise (Kineret acute, partner-distributed products). Comparable specialty pharma business model focused on rare and orphan diseases.
• Vertex Pharmaceuticals: Large specialty pharma with focus on rare diseases (cystic fibrosis, sickle cell). Comparable commercial model in launching and sustaining high-priced orphan drugs with strong patient support services.
• Sanofi (HAE portfolio): Markets Firazyr (icatibant) for acute HAE attacks and acquired the original Dyax HAE franchise. Broad incumbent with HAE presence and a deep rare disease commercial infrastructure.

Others

• BioCryst Pharmaceuticals (Parent): Public parent company (NASDAQ: BCRX) that owns and markets Orladeyo. Provides corporate context for the product line's pipeline strategy, capital structure, and overall enterprise value.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/orladeyo-berotralstat-hcp

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Orladeyo