Tacrolimus anhydrous
As of the edition of 20 October 2026, Tacrolimus anhydrous is a small molecule: marketed, first approved in 1994 (US); acts on FKBP1A; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Prograf
- First approved
- 8 April 1994 (US)
- Approvals on record
- 43 in 7 regions
- Holder of the most recent approval
- Clinigen; 11 holders in all
- Withdrawn from market
- 22 August 2008 (in some regions)
- Registered trials
- 868, 121 stopped early
- Disease areas
- Immune system; Blood and lymph; Cancer; Inherited and neonatal; Skin and connective tissue; Urinary and reproductive
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Astellas.
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 product6 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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Tacrolimus anhydrous.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| FKBP1A | Peptidyl-prolyl cis-trans isomerase FKBP1A | P62942 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 105 | 54 | 10 | 8 |
| Phase 1 | 93 | 51 | 14 | 20 |
| Phase 2 | 344 | 193 | 64 | 70 |
| Phase 3 | 128 | 88 | 15 | 14 |
| Phase 4 | 198 | 140 | 15 | 9 |
| All trials | 868 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Originator, Applicant, Later holder and Lead sponsor of trials | 1994 to now |
| LEO Pharma | Applicant, Acquired holder, Later holder and Lead sponsor of trials | 2001 to now |
| Chiesi Farmaceutici | Later holder and Lead sponsor of trials | 2014 to now |
| Veloxis Pharmaceuticals | Later holder and Lead sponsor of trials | 2015 to now |
| Nihon Pharmaceutical | Applicant | 2021 to now |
| Clinigen | Later holder | 2025 to now |