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TAKHZYRO (LANADELUMAB-FLYO)
TAKHZYRO (generic name: LANADELUMAB-FLYO) is a Plasma Kallikrein Inhibitor [EPC] drug developed by DYAX CORP.. It is currently FDA-approved for Hereditary angioneurotic edema.
At a glance
| Generic name | LANADELUMAB-FLYO |
|---|---|
| Sponsor | DYAX CORP. |
| Drug class | Plasma Kallikrein Inhibitor [EPC] |
| Target | Plasma kallikrein |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Approved indications
- Hereditary angioneurotic edema
Common side effects
- Injection site reactions
- Upper respiratory infection
- Headache
- Rash
- Dizziness
- Diarrhea
- Myalgia
- Increased aspartate transaminase
- Increased alanine transaminase
- Hypersensitivity
Key clinical trials
- Industry Alliance Platform Trial to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients (Phase 3)
- A Phase 1b, Randomized, Double-blind, Single and Repeat Dosing Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab When Added to Standard-of-Care in Subjects Hospitaliz (Phase 1)
- A Multi-center, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Lanadelumab (SHP643) in Chinese Subjects With Hereditary Angioedema (Phase 3)
- SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE (Phase 3)
- A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of a Single Dose of Lanadelumab Administered Subcutaneously in Healthy Adult Japanese Subjec (Phase 1)
- A Phase 3 Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Lanadelumab (SHP643) in Japanese Subjects With Hereditary Angioedema (Phase 3)
- A Post Marketing Surveillance Study (Usage Results Study) for Takhzyro in South Korea (N/A)
- Lanadelumab for Treatment of COVID-19 Disease (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TAKHZYRO CI brief — competitive landscape report
- TAKHZYRO updates RSS · CI watch RSS
- DYAX CORP. portfolio CI
Frequently asked questions about TAKHZYRO
What is TAKHZYRO?
TAKHZYRO (LANADELUMAB-FLYO) is a Plasma Kallikrein Inhibitor [EPC] drug developed by DYAX CORP., indicated for Hereditary angioneurotic edema.
What is TAKHZYRO used for?
TAKHZYRO is indicated for Hereditary angioneurotic edema.
Who makes TAKHZYRO?
TAKHZYRO is developed and marketed by DYAX CORP. (see full DYAX CORP. pipeline at /company/dyax-corp).
What is the generic name of TAKHZYRO?
LANADELUMAB-FLYO is the generic (nonproprietary) name of TAKHZYRO.
What drug class is TAKHZYRO in?
TAKHZYRO belongs to the Plasma Kallikrein Inhibitor [EPC] class. See all Plasma Kallikrein Inhibitor [EPC] drugs at /class/plasma-kallikrein-inhibitor-epc.
What development phase is TAKHZYRO in?
TAKHZYRO is FDA-approved (marketed).
What are the side effects of TAKHZYRO?
Common side effects of TAKHZYRO include Injection site reactions, Upper respiratory infection, Headache, Rash, Dizziness, Diarrhea.
What does TAKHZYRO target?
TAKHZYRO targets Plasma kallikrein and is a Plasma Kallikrein Inhibitor [EPC].
Related
- Drug class: All Plasma Kallikrein Inhibitor [EPC] drugs
- Target: All drugs targeting Plasma kallikrein
- Manufacturer: DYAX CORP. — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Hereditary angioneurotic edema
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing