Drug

Daxibotulinumtoxina

As of the edition of 20 October 2026, Daxibotulinumtoxina is a drug: marketed, first approved in 2022 (US); acts on SNAP25; US protection ends in 2034.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2022
Kind
Unknown
Brand name
Daxxify
First approved
7 September 2022 (US)
Approvals on record
2 in 1 region
Holder of the most recent approval
Crown
Registered trials
12, 0 stopped early
Disease areas
Nervous system; Ear, nose and throat; Eye; Lungs and airways; Mouth and teeth

US protection

US protection ends in 2034.

US protection ends in 2034, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Crown. The date is computed, not published.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

1 listing counts towards this date. The exact date and each listing are in the product.

See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Daxibotulinumtoxina.

Target

GeneProteinUniProt
SNAP25Synaptosomal-associated protein 25P60880

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 27610
Phase 32200
Phase 42110
All trials12

Who has held its approvals

CompanyRoleYears
CrownOriginator and Lead sponsor of trials2015 to now