Drug

Nebivolol

As of the edition of 20 October 2026, Nebivolol is a small molecule: marketed, first approved in 1996 (FR); acts on ADRB1.

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

The drug

Status
Marketed; latest approval 2012
Kind
Small molecule
Brand name
Bystolic
First approved
21 August 1996 (FR)
Approvals on record
12 in 5 regions
Holder of the most recent approval
AbbVie; 5 holders in all
Registered trials
62, 8 stopped early
Disease areas
Heart and blood vessels; Nervous system; Lungs and airways; Hormones; Skin and connective tissue; Bones, joints and muscles

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

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 Nebivolol.

Target

GeneProteinUniProt
ADRB1Beta-1 adrenergic receptorP08588

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated12612
Phase 14400
Phase 25410
Phase 3191321
Phase 4221325
All trials62

Who has held its approvals

CompanyRoleYears
ActavisApplicant and Lead sponsor of trials2007 to now
AbbVieApplicant and Acquired holder2012 to now