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Immediate Release Tacrolimus Capsule
Immediate Release Tacrolimus Capsule is a Small molecule drug developed by Roy D. Bloom, MD. It is currently FDA-approved. Also known as: IR-TAC, Prograf®.
Immediate Release Tacrolimus Capsule, marketed by Roy D. Bloom, MD, is an established immunosuppressive agent in the pharmaceutical market. The drug's key strength lies in its well-established mechanism and primary indication, which provide a solid foundation for its therapeutic use. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | Immediate Release Tacrolimus Capsule |
|---|---|
| Also known as | IR-TAC, Prograf® |
| Sponsor | Roy D. Bloom, MD |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (PHASE4)
- Tacrolimus Trial for Hereditary Hemorrhagic Telangiectasia (HHT) (PHASE2)
- To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients (PHASE4)
- Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients (NA)
- Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation (PHASE3)
- Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation (PHASE4)
- Envarsus XR in Lung Transplant (PHASE2)
- Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation. (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Immediate Release Tacrolimus Capsule CI brief — competitive landscape report
- Immediate Release Tacrolimus Capsule updates RSS · CI watch RSS
- Roy D. Bloom, MD portfolio CI
Frequently asked questions about Immediate Release Tacrolimus Capsule
What is Immediate Release Tacrolimus Capsule?
Who makes Immediate Release Tacrolimus Capsule?
Is Immediate Release Tacrolimus Capsule also known as anything else?
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Related
- Manufacturer: Roy D. Bloom, MD — full pipeline
- Also known as: IR-TAC, Prograf®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing