Labetalol
As of the edition of 20 October 2026, Labetalol is a small molecule: marketed, first approved in 1978 (ES); acts on ADRA1A, ADRA1B and ADRA1D and 6 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1984
- Kind
- Small molecule
- Brand name
- Normodyne
- First approved
- 1 December 1978 (ES)
- Approvals on record
- 26 in 3 regions
- Holder of the most recent approval
- Hikma Pharmaceuticals; 7 holders in all
- Registered trials
- 32, 5 stopped early
- Disease areas
- Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Nervous system; Chemically induced; Mental health
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
14 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product14 company-target rows are on route B because of Labetalol.
See the 14 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| ADRB2 | Beta-2 adrenergic receptor | P07550 |
| ADRB1 | Beta-1 adrenergic receptor | P08588 |
| ADRA2A | Alpha-2A adrenergic receptor | P08913 |
| ADRB3 | Beta-3 adrenergic receptor | P13945 |
| ADRA2B | Alpha-2B adrenergic receptor | P18089 |
| ADRA2C | Alpha-2C adrenergic receptor | P18825 |
| ADRA1D | Alpha-1D adrenergic receptor | P25100 |
| ADRA1A | Alpha-1A adrenergic receptor | P35348 |
| ADRA1B | Alpha-1B adrenergic receptor | P35368 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 5 | 3 | 0 |
| Phase 1 | 1 | 0 | 1 | 0 |
| Phase 2 | 10 | 8 | 0 | 2 |
| Phase 3 | 2 | 0 | 2 | 0 |
| Phase 4 | 11 | 5 | 2 | 3 |
| All trials | 32 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Earlier holder | 1984 to now |
| Merck & Co. | Later holder | 1984 to now |
| Sebela | Acquired holder | 2016 to now |
| Alvogen | Acquired holder | 2021 to now |
| Hikma Pharmaceuticals | Acquired holder | 2021 to now |