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Also known as Tacrolimus Capsules
Tacrolimus · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Tacrolimus | EXPERIMENTAL | Tacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited |
| Prograf Capsules | ACTIVE_COMPARATOR | Prograf Capsules of Astellas Pharma US, Inc., |
| Name | Type | Description |
|---|---|---|
| Tacrolimus Capsules | DRUG | Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: 1. The subjects should be healthy human between 18 and 45 years. 2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug. 3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter. 4. The subjects...
Tacrolimus is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is formulated as tacrolimus capsules and has been studied in Phase 1 clinical trials. The specific therapeutic indications for this asset are undisclosed.
Tacrolimus targets FKBP1A and acts as an inhibitor of that target. FKBP1A is an immunophilin protein, and tacrolimus binds it as part of its mechanism of action. This target class places tacrolimus among inhibitor-type small molecule agents.
Tacrolimus is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company whose shares trade under the ticker RDY. The company sponsored the bioavailability studies of tacrolimus capsules, 5 mg, that make up the clinical program for this asset.
Tacrolimus is in Phase 1 development. Both of its recorded clinical trials are Phase 1 bioavailability studies, and both are completed, with no active trials currently listed. It is an investigational asset and is not described as approved.
Tacrolimus has been studied in two completed Phase 1 bioavailability trials: NCT01132027, which assessed tacrolimus capsules, 5 mg, under non-fasting conditions, and NCT01131988, which assessed the same capsules under fasting conditions. Each trial enrolled 40 healthy volunteers in India.
Yes, Tacrolimus Capsules is an alternative name for Tacrolimus. Both names refer to the same Dr. Reddy's Laboratories Ltd asset, a small molecule FKBP1A inhibitor evaluated in Phase 1 bioavailability studies of the 5 mg capsule formulation.