Drug

Imlifidase

As of the edition of 20 October 2026, Imlifidase is an enzyme: marketed, first approved in 2020 (EU); acts on IGHG1, IGHG2 and IGHG3 and 1 more.

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

The drug

Status
Marketed; latest approval 2020
Kind
Enzyme
Brand name
Idefirix
First approved
25 August 2020 (EU)
Approvals on record
1 in 1 region
Holder of the most recent approval
Hansa Biopharma
Registered trials
21, 6 stopped early
Disease areas
Pregnancy and women's health; Urinary and reproductive; Immune system; Inherited and neonatal; Nervous system; Blood and lymph

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

4 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

4 company-target rows are on route B because of Imlifidase.

Targets

GeneProteinUniProt
IGHG1Immunoglobulin heavy constant gamma 1P01857
IGHG2Immunoglobulin heavy constant gamma 2P01859
IGHG3Immunoglobulin heavy constant gamma 3P01860
IGHG4Immunoglobulin heavy constant gamma 4P01861

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated3111
Phase 12101
Phase 212723
Phase 34211
All trials21

Who has held its approvals

CompanyRoleYears
Hansa BiopharmaApplicant and Lead sponsor of trials2013 to now