Tacrolimus: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Tacrolimus appears in the FDA drug-label database. Marketed as Tacrolimus.
- Boxed warning
- The FDA label for Tacrolimus carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Tacrolimus capsules are calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney or heart transplants and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [ see Clinical Studies (14.1) ] , liver transplants [ see Clinical Studies (14.2) ] and heart transplant [ see Clinical Studies (14.3) ] , and pediatric patients receiving allogeneic liver transplants [ see Clinical Studies (14.2) ] in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. — Mylan Pharmaceuticals Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2020-03-23 |
| Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Astellas Pharma US Inc. | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2024-12-23 |
| Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. — Dr. Reddy's Laboratories, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2023-02-08 |
| Failed Moisture Limits — Strides Pharma Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2020-12-22 |
| Failed USP Content Uniformity Requirements: OOS result reported on retained samples. — Mylan LLC. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-06-29 |
Phase breakdown
Conditions being studied
Recruiting trials involving Tacrolimus
- A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
- Allo HSCT for High Risk Hemoglobinopathies
- Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
- Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Common questions
Is Tacrolimus FDA-approved?
Yes, marketed as Tacrolimus. Its FDA label carries a boxed warning.
How many recruiting trials involve Tacrolimus?
5 recruiting trials across 14 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.