Sotalol
As of the edition of 20 October 2026, Sotalol is a small molecule: marketed, first approved in 1978 (FR); acts on ADRB1, ADRB2 and KCNH2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Betapace
- First approved
- 8 August 1978 (FR)
- Approvals on record
- 15 in 3 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 5 holders in all
- Registered trials
- 17, 1 stopped early
- Disease areas
- Heart and blood vessels; Inherited and neonatal; Chemically induced
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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Sotalol.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 5 | 0 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 4 | 0 | 1 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Arbor Pharmaceuticals | Later holder | 2014 to now |
| Altathera Pharmaceuticals | Acquired holder | 2015 to now |
| Azurity Pharmaceuticals | Acquired holder | 2022 to now |
| Legacy Pharma Inc Sezc | Acquired holder | 2026 to now |