Drug

Daclizumab

As of the edition of 20 October 2026, Daclizumab is an antibody: withdrawn from the market in 2018; acts on IL2RA; US protection ended in 2009.

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

The drug

Status
Withdrawn from market, 2018
Kind
Antibody
Brand name
Zenapax
First approved
10 December 1997 (US)
Approvals on record
3 in 1 region
Holder of the most recent approval
Biogen; 2 holders in all
Withdrawn from market
27 March 2018 (in some regions)
Registered trials
60, 7 stopped early
Disease areas
Immune system; Hormones; Nutrition and metabolism; Blood and lymph; Eye; Nervous system

US protection

US protection ended in 2009.

US protection ended in 2009, 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 Roche. 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 A because of this drug.

Companies on route A for this drug

In the product

1 company is on route A because of Daclizumab.

Target

GeneProteinUniProt
IL2RAInterleukin-2 receptor subunit alphaP01589

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated2101
Phase 14400
Phase 2332904
Phase 311902
Phase 410900
All trials60

Who has held its approvals

CompanyRoleYears
RocheAcquired holder and Lead sponsor of trials1999 to now
BiogenLater holder and Lead sponsor of trials2010 to now