Tacrolimus
Small molecule targets BMPR2, IL2 via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | PROGRAF | — | 1997-04-22 – 2021-07-16 | fda.gov ↗ |
| Label expansion | US (FDA) | ASTAGRAF XL | — | 2018-11-29 | fda.gov ↗ |
| Filed | EU (EMA) | — | inhibition of rejection in organ transplantation | 2006-01-31 | “has submitted an MAA for the immunosuppressant FK506 Modified Release Formulation (generic name: tacrolimus) to the European Medicines Agency (EMEA)” astellas.com ↗ |
| Filed | US (FDA) | — | prevention of organ rejection in organ transplant recipients | 2005-12-26 | “has submitted to the FDA an NDA for the immunosuppressant FK506 modified release formulation (generic name: tacrolimus)” astellas.com ↗ |
| Approved | EU (EMA) | Protopic | — | 2002-02-27 | europa.eu ↗ |
| Approved | US (FDA) | PROGRAF | — | 1994-04-08 | fda.gov ↗ |
Trials 474 · started per year
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Hoffmann-La Roche | Results FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy roche.com ↗
The priority review is based on the positive phase III MAJESTY results, which show superiority of Gazyva/Gazyvaro over an immunosuppressive therapy, tacrolimus, in adults with pMN. |
| 2026-01-26 | Novaliq GmbH | Regulatory Novaliq Receives FDA IND Clearance to Advance NOV05 in a Phase II Clinical Trial in Non-Infectious Anterior Uveitis novaliq.com ↗
Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on its unique water-free EyeSol ® drug category, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for NOV05, the company’s first IND for treating inner-eye diseases. |
| 2025-05-15 | Lipella Pharmaceuticals, Inc. | Results Lipella Pharmaceuticals to Present Phase 2a Data for LP-10 at the 2025 AAOM/EAOM International Meeting lipella.com ↗
Treatment at the 0.50 mg dose demonstrated statistically significant improvements in multiple endpoints: |
| 2025-04-23 | Lipella Pharmaceuticals, Inc. | Results Lipella Pharmaceuticals Abstract Accepted for Podium Presentation at the 2025 AAOM/EAOM International Meeting lipella.com ↗
Topline study results demonstrate clinically meaningful improvements in OLP Visible lesion resolution during treatment; return toward baseline post-dosing supports localized activity |
| 2025-04-22 | Lipella Pharmaceuticals, Inc. | Results Lipella Reports Positive Phase 2a Results from Second LP-310 Cohort in Oral Lichen Planus lipella.com ↗
today announced positive topline results from the second cohort (0.50 mg) of its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10, for the treatment of oral lichen planus (OLP). |
| 2025-02-06 | Lipella Pharmaceuticals, Inc. | Regulatory Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus lipella.com ↗ |
| 2024-12-08 | Orca Biosystems, Inc. | Results Orca Bio Presents Three-Year Survival Data with Orca-T® in Patients with Hematological Malignancies at the 66th ASH Annual Meeting orcabio.com ↗
The results of a three-year follow-up analysis with Orca-T plus single-agent tacrolimus (TAC) showed encouraging overall survival (OS) in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). |
| 2024-11-21 | Lipella Pharmaceuticals, Inc. | Results Lipella Pharmaceuticals Announces Completion of First Cohort in Phase 2a Trial of LP-310 lipella.com ↗
Pharmacokinetic data demonstrated that whole blood tacrolimus levels in all patients were either undetectable or minimal, highlighting LP-310’s potential to deliver localized therapeutic effects while minimizing systemic exposure. |
| 2023-12-21 | HK inno.N Corporation | Results HK inno.N displays distinctive K-CAB clinical trial results inno-n.com ↗
The study results showed that K-CAB did not affect the minimum plasma concentration of immunosuppressants. |
| 2023-08-17 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03% glenmarkpharma.com ↗
Glenmark Pharmaceuticals Ltd. (Glenmark), a research‐led, integrated, global pharmaceutical company has received final approval by the United States Food & Drug Administration (U.S. FDA) Tacrolimus Ointment, 0.03%, the generic version of Protopic1 Ointment, 0.03%, of Leo Pharma AS. |
| 2020-11-12 | Lupin Limited | Regulatory Lupin’s Alliance Partner Concord Receives U.S. FDA Approval for Tacrolimus Capsules USP lupin.com ↗
Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg |
| 2020-11-11 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf® 1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc. |
| 2019-06-06 | Novartis Pharmaceuticals | Results Novartis presents first-of-its-kind histology data with iscalimab (CFZ533) suggesting the extended survival of transplanted organs may be possible novartis.com ↗
In this analysis, iscalimab demonstrated lower chronic allograft damage index (CADI) scores compared with tacrolimus (current standard-of-care), with normal renal histology seen in three of five patients (60%) on iscalimab vs none of seven on tacrolimus[1]. |
| 2018-07-10 | VIVUS LLC | Results VIVUS Announces Positive Results from a Phase 1 Clinical Trial of VI-0106 vivus.com ↗ |
| 2017-09-06 | VIVUS LLC | Regulatory VIVUS Announces Tacrolimus Receives Orphan Drug Designation in the European Union for the Treatment of Pulmonary Arterial Hypertension vivus.com ↗ |
| 2015-04-08 | Janssen Research & Development, LLC | Results Janssen Highlights Hepatitis C Virus Development Program at The International Liver Congress® 2015 of the European Association for the Study of the Liver (EASL) jnj.com ↗ |
| 2013-10-01 | Bristol-Myers Squibb | Results Bristol-Myers Squibb to Present Range of New Hepatitis C Data at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting bms.com ↗
Daclatasvir Pharmacokinetics in Healthy Subjects: No Clinically-Significant Drug-Drug Interactions with Cyclosporine or Tacrolimus |
| 2013-07-19 | Astellas Pharma Inc | Regulatory Astellas Announces FDA Approval of ASTAGRAF XLTM (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipients astellas.com ↗
Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) has approved ASTAGRAF XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. |
| 2013-06-14 | Astellas Pharma Inc | Regulatory Approval of Prograf® capsules in Japan for the additional indication of interstitial pneumonia associated with polymyositis /dermatomyositis astellas.com ↗
Astellas Pharma Inc . (“Astellas”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka) announced today that it has been granted approval in Japan for the additional indication of interstitial pneumonia associated with polymyositis/dermatomyositis for Prograf® capsules 0.5mg, 1.0mg (generic name: tacrolimus hydrate). |
| 2011-07-28 | Astellas Pharma Inc | Regulatory Approval for Additional Indication of Small Bowel Transplant, for Prograf® and Graceptor® , in Japan astellas.com ↗
announced today that it was granted approval for the additional indication of the prophylaxis of organ rejection in patients receiving allogeneic small bowel transplants, for Prograf® and Graceptor® (generic name: tacrolimus hydrate), in Japan. |
| 2009-10-16 | Astellas Pharma Inc | Regulatory Approval of Additional Indications for the immunosuppressant Prograf®for Myasthenia Gravis in Japan astellas.com ↗
Prograf has now been approved for “myasthenia gravis” covering such not included in past indication. |
| 2009-08-11 | Astellas Pharma Inc | Regulatory Astellas Announces the Outcome of its Citizen Petition in the US astellas.com ↗
the U.S. Food and Drug Administration (FDA) has substantially denied the company’s Citizen Petition*1 |
| 2009-07-07 | Astellas Pharma Inc | Regulatory Approval of Additional Indications for the immunosuppressant Prograf® for Ulcerative Colitis in Japan astellas.com ↗
today announced that it was granted approval for moderately/severely refractory (steroid resistance and steroid dependency ) ulcerative colitis as additional indication for the immunosuppressant Prograf® (generic name: tacrolimus hydrate) |
| 2006-04-21 | Astellas Pharma Inc | Regulatory Prograf Now Approved for Prophylaxis Use in Heart Transplantation across Europe astellas.com ↗
Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) today announced that the European Commission has approved the immunosuppressant Prograf® (generic name: tacrolimus) for the prophylaxis use of transplant rejection in recipients of heart transplants in all EU countries*. |
| 2006-01-31 | Astellas Pharma Inc | Regulatory Recent Progress in the New Drug Development astellas.com ↗
The European subsidiary of Astellas has submitted an MAA for the immunosuppressant FK506 Modified Release Formulation (generic name: tacrolimus) to the European Medicines Agency (EMEA) with the proposed indication of the inhibition of rejection in organ transplantation. |
| 2005-12-26 | Astellas Pharma Inc | Regulatory NDA for Immunosuppressant FK506 Modified Release Formulation Submitted in the US astellas.com ↗
has submitted to the FDA an NDA for the immunosuppressant FK506 modified release formulation (generic name: tacrolimus) |
| 2005-04-11 | Astellas Pharma Inc | Regulatory Prograf ® Is Approved For Additional Indication of Rheumatoid Arthritis astellas.com ↗
A supplemental application for the treatment of rheumatoid arthritis was submitted in Japan in November 2002 and approved on April 11, 2005. |
All press releases naming this drug 37 releases
Evidence & citations 56 cited values
Every value below carries the sentence it was read from. 1,159 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tacrolimus | “Thirty nine patients were assigned, through a randomized design, to receive tacrolimus ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%,...” NCT04718311 ↗1084“Envarsus®, the once-daily prolonged-release formulation of tacrolimus, offers the same therapeutic efficacy as the conventional twice-daily immediate-release tacrolimus...” PMID 38444519 ↗ Feb 2024 “Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive...” NCT02885610 ↗ “Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the...” NCT03423225 ↗ “The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate,...” NCT03320642 ↗ “Standard of Care Therapy. Eligible patients should be on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF...” NCT03657342 ↗ “Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on...” NCT03603548 ↗ “The development of Advagraf (tacrolimus extended release capsules), which is approved for prevention of rejection in kidney transplant recipients, now provides an opportunity...” NCT02426502 ↗ “A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation...” NCT02040584 ↗ “This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice...” NCT03373227 ↗ “Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named...” NCT04489134 ↗ |
| Known as | ADOPORT | “Drug conversion from Tacrolimus (Prograf® or Adoport®) to LCP-Tacrolimus (Envarsus®)” NCT02961608 ↗2“Immediate release Tacrolimus (Prograf/Adoport)” NCT03465410 ↗ “Tacrolimus monohydrate (ADOPORT®)” NCT03076151 ↗ |
| Known as | Advagraf | “Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the...” NCT03423225 ↗32“Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on...” NCT03603548 ↗ “The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day...” NCT04761731 ↗ “A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf®...” NCT01339468 ↗ “Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named...” NCT04489134 ↗ “The aim of the conversion is to investigate the effects of the multi-drug resistance (MDR1, gene symbol ABCB1) genotype on the trough blood levels of tacrolimus modified...” NCT03751332 ↗ “Current formulations of tacrolimus, such as Prograf® and Advagraf™, exhibit limitations in terms of pharmacokinetics and tolerability, related in part to suboptimal bioavailability.” PMID 37170284 ↗ May 2023 “A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers” NCT01681134 ↗ “Conversion from Prograf® (tacrolimus administered twice daily) to Advagraf® (once-daily prolonged-release tacrolimus) at day 7±3” NCT02105155 ↗ “Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.” NCT01206569 ↗ “Advagraf is a FK506 formulation that has been demonstrated to lower the risk of nonadherence” NCT04237246 ↗ |
| Known as | ADVAGRAF: Tacrolimus Sustained-release Capsules | “ADVAGRAF: Tacrolimus Sustained-release Capsules” NCT01328834 ↗ |
| Known as | Astagraf XL | “Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients” NCT03194321 ↗ |
| Known as | Envarsus | “Envarsus®, the once-daily prolonged-release formulation of tacrolimus, offers the same therapeutic efficacy as the conventional twice-daily immediate-release tacrolimus...” PMID 38444519 ↗ Feb 202412“Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on...” NCT03603548 ↗ “The hypothesis of this study is that kidney transplant recipients receiving once-a-day extended release tacrolimus (Envarsus) will have outcomes that are not inferior to those...” NCT03438773 ↗ “Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named...” NCT04489134 ↗ “Tacrolimus XR (Envarsus) is a once daily formulation with delayed absorption and lower peak levels while maintaining similar trough levels as seen with IR tacrolimus.” NCT04917718 ↗ “Envarsus® is also a prolonged-release once-daily tacrolimus formulation, developed using MeltDose™ drug-delivery technology to increase drug bioavailability” PMID 37170284 ↗ May 2023 “a low exposure Tacrolimus once-daily (Envarsus®) regimen in combination with Everolimus will be evaluated in elderly transplant recipients” NCT03797196 ↗ “Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant” NCT03713645 ↗ “Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus” NCT02432833 ↗ “Tacrolimus and Tacrolimus Extended Release Oral Tablet [Envarsus]” NCT04496401 ↗ “Patients will be converted to Envarsus formulation of tacrolimus” NCT03461445 ↗ |
| Known as | Envarsus XR | “This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR)...” NCT04225988 ↗9“Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation.” NCT03270462 ↗ “using extended release tacrolimus (Envarsus XR, Veloxis), will provide more stable, more effective, and less toxic levels of tacrolimus in renal allograft recipients.” NCT03511560 ↗ “Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients.” NCT06354179 ↗ “Convert from tacrolimus immediate release to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours” NCT04711291 ↗ “ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant” NCT02956005 ↗ “LCP-Tacro (Envarsus® XR, Veloxis Pharmaceuticals), a new once-daily formulation of tacrolimus” NCT03289650 ↗ “Envarsus XR (0.13mg/kg/day) will be administered once a day.” NCT04773392 ↗ |
| Known as | ER-TAC | “The aim of this study was to assess the efficacy and safety of low-dose SRL with extended-release tacrolimus (ER-TAC) versus MMF with ER-TAC.” PMID 28810721 ↗ Aug 2017 |
| Known as | FK506 | “A Steady-State Head-to-Head Pharmacokinetic Comparison of All FK-506
(Tacrolimus) Formulations (ASTCOFF): An Open-Label, Prospective, Randomized,
Two-Arm, Three-Period...” PMID 27340950 ↗ Aug 201635“Oral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI” NCT06490562 ↗ “Tacrolimus, also known as FK506, is an agent mainly used after allogeneic organ transplant to lower risk of organ rejection.” NCT03540472 ↗ “Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell activation and cytokine release.” NCT01333410 ↗ “Tacrolimus (FK-506) (IV or oral (po)) beginning Day 5 with dose adjusted to maintain a trough level of 5-15 ng/mL.” NCT05298358 ↗ “Among topical immunosuppressants the most used ones are tacrolimus, also known as FK506 and cyclosporine A (CsA).” NCT01850979 ↗ “Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.” NCT05929248 ↗ “Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.” NCT04956484 ↗ “Tacrolimus, formerly known as FK506, is a macrolide antibiotic possessing immunosuppressive properties.” NCT06203470 ↗ “0.1% tacrolimus (FK-506) ophthalmic ointment with 2% cyclosporine eye drops in the treatment of VKC.” NCT01068054 ↗ “Advagraf is a FK506 formulation that has been demonstrated to lower the risk of nonadherence” NCT04237246 ↗ |
| Known as | FK506E | “Other Names: * FK506E * MR4 * tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug:...” NCT01435291 ↗ |
| Known as | Fujimycin | “Fujimycin” NCT02220985 ↗ |
| Known as | Hecoria | “Hecoria” NCT03096782 ↗1“Hecoria” NCT02220985 ↗ |
| Known as | Immediate-release tacrolimus | “Immediate-release tacrolimus for at least 3 months after liver transplantation, and then convert to tacrolimus sustained-release capsules at a ratio of 1:1 to 1:1.2; Take the...” NCT06183892 ↗2“Our study compared dosing of LCPT with current standard-of-care tacrolimus [immediate-release tacrolimus (IR-Tac) or prolonged-release tacrolimus (PR-Tac)] during the 6 months...” PMID 36017158 ↗ Mar 2022 “Comparison of Early Conversion to LCP-Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients.” PMID 40294109 ↗ May 2025 |
| Known as | IR tacrolimus | “As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacrolimus to Envarsus XR.” NCT04420195 ↗1“intermediate release tacrolimus (IR-tacrolimus, IR-tacro).” NCT04469842 ↗ |
| Known as | IR-Tac | “Our study compared dosing of LCPT with current standard-of-care tacrolimus [immediate-release tacrolimus (IR-Tac) or prolonged-release tacrolimus (PR-Tac)] during the 6 months...” PMID 36017158 ↗ Mar 20222“rather than immediate release tacrolimus (IR-Tac) which is prescribed as a two doses per day (every 12 hours)” NCT04711291 ↗ “immediate-release tacrolimus (IR-Tac)” PMID 29162334 ↗ Nov 2017 |
| Known as | IR-tacro | “intermediate release tacrolimus (IR-tacrolimus, IR-tacro).” NCT04469842 ↗ |
| Known as | IRT | “We conducted a prospective, open-label trial of lung transplant recipients who underwent early conversion (within 30 days) to LCP tacrolimus (LCPT, n = 40) and compared...” PMID 40294109 ↗ May 2025 |
| Known as | LCP-Tac | “This observational retrospective study analyzed the effectiveness and safety of conversion from twice-daily immediate-release tacrolimus (IR-Tac) or once-daily...” PMID 31815310 ↗ Dec 2019 |
| Known as | LCP-Tacro | “LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects...” NCT01438710 ↗6“Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named...” NCT04489134 ↗ “LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL” NCT00608894 ↗ “Long-acting Tacrolimus (LCP-tacrolimus) may have the potential to bridge the balance of providing potent immunosuppression” NCT04469842 ↗ “LCP-Tacro is a tablet containing the same active ingredient (tacrolimus) that is in Prograf capsules” NCT00772148 ↗ “ENVARSUS® (LCP Tacro - extended release tacrolimus)” NCT04496401 ↗ “LCP Tacro (tacrolimus)” NCT00496483 ↗ |
| Known as | LCP-tacrolimus | “Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients.” NCT06354179 ↗3“Comparison of Early Conversion to LCP-Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients.” PMID 40294109 ↗ May 2025 “Long-acting Tacrolimus (LCP-tacrolimus) may have the potential to bridge the balance of providing potent immunosuppression” NCT04469842 ↗ “A new once-daily tacrolimus formulation, LCP-tacrolimus (LCPT), has been developed” PMID 36017158 ↗ Mar 2022 |
| Known as | LCPT | “We conducted a prospective, open-label trial of lung transplant recipients who underwent early conversion
(within 30 days) to LCP tacrolimus (LCPT, n = 40) and compared...” PMID 40294109 ↗ May 20253“The aim of this study was to compare the pharmacokinetic profile, tolerability, and safety of a novel once-daily extended-release formulation of tacrolimus (LCPT) with that of...” PMID 29965950 ↗ Oct 2018 “A new once-daily tacrolimus formulation, LCP-tacrolimus (LCPT), has been developed” PMID 36017158 ↗ Mar 2022 “once-daily extended-release tacrolimus (LifeCycle Pharma Tac [LCPT])” PMID 29162334 ↗ Nov 2017 |
| Known as | LifeCycle Pharma Tac | “once-daily extended-release tacrolimus (LifeCycle Pharma Tac [LCPT])” PMID 29162334 ↗ Nov 2017 |
| Known as | LP-10 | “LP-10, a novel liposomal tacrolimus oral rinse” PMID 41174333 ↗ Oct 2025 |
| Known as | LTac | “everolimus (EVR), low-dose tacrolimus (LTac)” PMID 28141897 ↗ Mar 2017 |
| Known as | LTacrolimus Topical | “Drug: LTacrolimus Topical” NCT04705584 ↗ |
| Known as | MR4 | “Other Names: * FK506E * MR4 * tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug:...” NCT01435291 ↗ |
| Known as | NOV05 | “A Phase 2, Randomized, Double-Masked, Controlled, Proof-of-Concept Study to Evaluate the Safety and Biological Activity of a Water-free Tacrolimus Ophthalmic Solution (NOV05)...” NCT07285070 ↗ |
| Known as | PR-Tac | “Our study compared dosing of LCPT with current standard-of-care tacrolimus [immediate-release tacrolimus (IR-Tac) or prolonged-release tacrolimus (PR-Tac)] during the 6 months...” PMID 36017158 ↗ Mar 2022 |
| Known as | Prograf | “Envarsus®, the once-daily prolonged-release formulation of tacrolimus, offers the same therapeutic efficacy as the conventional twice-daily immediate-release tacrolimus...” PMID 38444519 ↗ Feb 202464“Tacrolimus (Prograf) is an immunosuppressant that inhibits calcineurin and T cell activation, and is commonly used to prevent solid organ transplant rejection1 and graft versus...” NCT06692426 ↗ “Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on...” NCT03603548 ↗ “This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice...” NCT03373227 ↗ “A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf®...” NCT01339468 ↗ “Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named...” NCT04489134 ↗ “This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus...” NCT03511560 ↗ “Brand: Prograf Capsules, 1.0mg Tacrolimus capsules containing white to off white powder equivalent to 1.0 mg of anhydrous tacrolimus are hard gelatin capsules with white opaque...” NCT01889758 ↗ “Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the...” NCT01438710 ↗ “1. Tacrolimus (Prograf®) At 6 months post-transplantation, patients will have Prograf® tapered by 25% per week such that they will be off of this medication by 7 months...” NCT02117596 ↗ “Current formulations of tacrolimus, such as Prograf® and Advagraf™, exhibit limitations in terms of pharmacokinetics and tolerability, related in part to suboptimal bioavailability.” PMID 37170284 ↗ May 2023 |
| Known as | Prograf (tacrolimus) | “Prograf (tacrolimus)” NCT01492894 ↗ |
| Known as | Prograf capsules (tacrolimus) | “Prograf® capsules (tacrolimus)” NCT00935298 ↗ |
| Known as | prolonged-release tacrolimus | “Our study compared dosing of LCPT with current standard-of-care tacrolimus [immediate-release tacrolimus (IR-Tac) or prolonged-release tacrolimus (PR-Tac)] during the 6 months...” PMID 36017158 ↗ Mar 20221“A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety.” NCT06147648 ↗ |
| Known as | Protopic | “Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%)” NCT04114097 ↗6“Protopic® (Tacrolimus) 0.1% ointment” NCT03152019 ↗ “Tacrolimus 0.03% ointment (Protopic)” NCT00443105 ↗ “Protopic” NCT03096782 ↗ |
| Known as | TAC | “The aim of this study was to compare the long-term safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) plus mycophenolate mofetil (MMF) or...” PMID 19744223 ↗ Sep 200938“In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse...” NCT01207297 ↗ “An Exploratory Evaluation of Early Use of Everolimus (EVE) on Tacrolimus (TAC)-Based Immunosuppressive Regiment vs. Mycophenolate Sodium (MPS) on Cytomegalovirus (CMV)...” NCT01927588 ↗ “The efficacy and safety of tacrolimus (TAC) and cyclophosphamide (CTX) were prospectively examined in steroid-dependent or steroid-resistant primary focal segmental...” PMID 23343906 ↗ Jan 2013 “This random, open, control and multicenter clinical trial mainly aims to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous...” NCT03864250 ↗ “The study compared the clinical effectiveness of topical Tacrolimus (TAC) in patches or gel with Triamcinolone acetonide (TRI) gel for erosive/atrophic oral lichen planus (OLP)” PMID 36788511 ↗ Feb 2023 “The calcineurin inhibitors (CNIs) cyclosporine (CsA) and tacrolimus (Tac) are implicated in post-transplant complications such as cardiovascular morbidity.” PMID 23190385 ↗ Nov 2012 “The written informed consent to conversion of either tacrolimus (TAC; Prograf®) or cyclosporin A (CSA; Sandimmun Neoral®) to TAC MR4 will be obtained.” NCT03751332 ↗ “Tacrolimus (TAC) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice.” NCT02891603 ↗ “Tacrolimus (TAC) to ciclosporin A (CSA) conversion studies in stable kidney transplant recipients have reported varying effects on graft function.” PMID 26270340 ↗ Aug 2015 “One year survival of islet cell grafts has been reproducibly achieved under combination immune therapy including tacrolimus (TAC).” PMID 18212631 ↗ Jan 2008 |
| Known as | TAC MR4 | “The written informed consent to conversion of either tacrolimus (TAC; Prograf®) or cyclosporin A (CSA; Sandimmun Neoral®) to TAC MR4 will be obtained.” NCT03751332 ↗ |
| Known as | TAC-ER | “The aim of this study (ClinicalTrials.gov, NCT01744470) was to determine the efficacy and safety of two different doses of extended-release tacrolimus (TacER) in kidney...” PMID 27862923 ↗ Jan 20171“Tacrolimus extended-release (TAC-ER; Astagraf XL® ) is utilized in many immunosuppressive regimens post-renal transplantation.” PMID 31206808 ↗ Jul 2019 |
| Known as | Tacforius | “Tacforius” NCT03670966 ↗ |
| Known as | Tacni | “Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center” NCT01698541 ↗ |
| Known as | TACRO | “We conducted a prospective clinical trial testing nivolumab (NIVO) + tacrolimus (TACRO) + prednisone (PRED) ± ipilimumab (IPI) in KTR with advanced cutaneous cancers.” PMID 38252910 ↗ Jan 20243“with planned dose reductions of tacrolimus (Tacro) over the first year postoperatively.” PMID 14742990 ↗ Jan 2004 “Tacrolimus (Tacro™)” NCT00765661 ↗ “Tacrolimus (Tacro)” NCT04339777 ↗ |
| Known as | TacroBell | “Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.” NCT04102943 ↗ |
| Known as | tacrolimus (FK 506) | “tacrolimus (FK 506)” NCT01707004 ↗ |
| Known as | tacrolimus (Prograf) | “Tacrolimus (Prograf®)” NCT00679042 ↗5“Tacrolimus (Prograf®)” NCT02213068 ↗ “tacrolimus (Prograf)” NCT01005706 ↗ “Tacrolimus, Prograf” NCT00302536 ↗ “Tacrolimus: PROGRAF” NCT00922129 ↗ “Tacrolimus,Prograf” NCT00302549 ↗ |
| Known as | Tacrolimus capsules（CYONSE） | “Tacrolimus capsules（CYONSE®）” NCT04048161 ↗ |
| Known as | tacrolimus modified release | “The aim of the conversion is to investigate the effects of the multi-drug resistance (MDR1, gene symbol ABCB1) genotype on the trough blood levels of tacrolimus modified...” NCT03751332 ↗ |
| Known as | tacrolimus modified/prolonged release | “Other Names: * FK506E * MR4 * tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug:...” NCT01435291 ↗ |
| Known as | Tacrolimus monohydrate | “Tacrolimus monohydrate (ADOPORT®)” NCT03076151 ↗ |
| Known as | tacrolimus MR4 | “Tacrolimus with modified galenic (tacrolimus MR4; Advagraf®) once daily.” NCT03751332 ↗ |
| Known as | Tacrolimus Sustained-release Capsules | “Drug: Tacrolimus Sustained-release Capsules” NCT06183892 ↗1“Drug: Tacrolimus Sustained-release Capsules” NCT06147648 ↗ |
| Known as | Tacrolimus, Prograf(R) | “Tacrolimus, Prograf(R)” NCT00360685 ↗ |
| Known as | Tacrolimus/Prograf/FK506 | “Tacrolimus/Prograf®/FK506” NCT00905515 ↗ |
| Known as | TCL | “Tacrolimus (TCL) or Cyclosporine A (CsA)” NCT04705584 ↗ |
| Known as | ◦Drug: Tacrolimus | “◦Drug: Tacrolimus” NCT01983761 ↗ |
| Action | Inhibit | “acts as a calcineurin inhibitor” NCT00117702 ↗ |
| Modality | Small molecule | “Tacrolimus is a macrolide immunosuppressant” NCT00117702 ↗ |
| Route | Intravenous | “IV beginning one day before stem cell infusion” NCT00002831 ↗ |
| Target | IL2 | “inhibiting the expression of cytokine genes, such as IL-2” NCT00317681 ↗ |