Drug

Botulinum toxin type a

As of the edition of 20 October 2026, Botulinum toxin type a is a protein: marketed, first approved in 2009 (JP); acts on SNAP25.

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

The drug

Status
Marketed; latest approval 2019
Kind
Protein
Brand name
Nuceiva
First approved
21 January 2009 (JP)
Approvals on record
12 in 2 regions
Holder of the most recent approval
GSK; 3 holders in all
Registered trials
337, 29 stopped early
Disease areas
Nervous system; Bones, joints and muscles; Urinary and reproductive; Pregnancy and women's health; Heart and blood vessels; Skin and connective tissue

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

2 companies on route B because of this drug.

Companies on route B for this drug

In the product

2 companies are on route B because of Botulinum toxin type a.

Target

GeneProteinUniProt
SNAP25Synaptosomal-associated protein 25P60880

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated7949104
Phase 1241901
Phase 2776217
Phase 311381812
Phase 4443025
All trials337

Who has held its approvals

CompanyRoleYears
AbbVieLater holder and Lead sponsor of trials2002 to now
GSKApplicant and Lead sponsor of trials2006 to now
EvolusApplicant and Lead sponsor of trials2015 to now