Landiolol
As of the edition of 20 October 2026, Landiolol is a small molecule: marketed, first approved in 2002 (JP); acts on ADRB1; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Rapiblyk
- First approved
- 5 July 2002 (JP)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Aop Health; 4 holders in all
- Registered trials
- 14, 0 stopped early
- Disease areas
- Heart and blood vessels; Infections; Nervous system
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Aop Health.
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 product2 listings count towards this date. The exact date and each listing are in the product.
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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 product1 company is on route B because of Landiolol.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADRB1 | Beta-1 adrenergic receptor | P08588 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 5 | 4 | 0 | 0 |
| Phase 3 | 6 | 4 | 2 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ono Pharmaceutical | Originator and Lead sponsor of trials | 1996 to now |
| AOP Orphan Pharmaceuticals | Applicant and Lead sponsor of trials | 2011 to now |
| Aop Health | Acquired holder | 2025 to now |