Ibudilast
As of the edition of 20 October 2026, Ibudilast is a small molecule: marketed, first approved in 1989 (JP); acts on PDE3A, PDE4A and PDE4B and 3 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1989
- Kind
- Small molecule
- First approved
- 1 May 1989 (JP)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Kyorin Pharmaceutical
- Registered trials
- 17, 0 stopped early
- Disease areas
- Nervous system; Chemically induced; Mental health; Infections; Nutrition and metabolism; Immune system
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
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Ibudilast.
See the 6 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 |
|---|---|---|
| PDE5A | cGMP-specific 3',5'-cyclic phosphodiesterase | O76074 |
| PDE4A | 3',5'-cyclic-AMP phosphodiesterase 4A | P27815 |
| PDE4B | 3',5'-cyclic-AMP phosphodiesterase 4B | Q07343 |
| PDE4C | 3',5'-cyclic-AMP phosphodiesterase 4C | Q08493 |
| PDE4D | 3',5'-cyclic-AMP phosphodiesterase 4D | Q08499 |
| PDE3A | cGMP-inhibited 3',5'-cyclic phosphodiesterase 3A | Q14432 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 10 | 9 | 0 | 0 |
| Phase 3 | 2 | 1 | 1 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Kyorin Pharmaceutical | Originator | 1989 to now |