Takhzyro
Plasma kallikrein inhibitor (monoclonal antibody). Developed by Takeda. Clinical, regulatory, and source evidence are connected below.
Latest signals
The three most recent source-backed changes linked to this drug.
N/A 路 RECRUITING 路 Takeda
Phase 2 路 COMPLETED 路 Vanderbilt University Medical Center
N/A 路 ACTIVE_NOT_RECRUITING 路 Takeda
Approved uses
The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.
1 INDICATIONS AND USAGE TAKHZYRO 庐 is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older.
Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.
EMA's summary; the full indication is in the product information on the EPAR page.
Regulatory history
US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.
Patents and exclusivity
Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.
The Purple Book lists no licensed biosimilar.
FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.
Safety
The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.
The current US label has no boxed warning.
None on FDA's list names this drug.
Clinical trials
A focused view of recently updated studies 路 20 linked records.
Takeda 路 Updated Oct 15, 2026
Vanderbilt University Medical Center 路 Updated Aug 19, 2026
Takeda 路 Updated Aug 4, 2026
Takeda 路 Updated Jul 14, 2026
Takeda 路 Updated May 11, 2026
Takeda 路 Updated Mar 31, 2026
Regulatory timeline
Verified regulatory records in reverse chronological order.
No regulatory event is available in this snapshot.
Related intelligence
Records connected through the current intelligence graph.
Source evidence
Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.
