Arimoclomol
As of the edition of 20 October 2026, Arimoclomol is a small molecule: marketed, first approved in 2024 (US); US protection ends in 2041.
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
- Miplyffa
- First approved
- 20 September 2024 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Zevra
- Registered trials
- 9, 4 stopped early
- Disease areas
- Nervous system; Nutrition and metabolism; Inherited and neonatal; Blood and lymph; Bones, joints and muscles
US protection
US protection ends in 2041.
The last listed US drug-substance patent ends in 2041. The application that gives this date is held by Zevra.
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 product12 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 12 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 2 |
| Phase 3 | 4 | 2 | 0 | 2 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Zevra | Originator | 2024 to now |