evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.

Start Date03 Oct 2025

Sponsor / Collaborator

Al-Azhar University

NCT06701825 / Not yet recruitingPhase 4IIT

A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort

This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.

Start Date01 Feb 2025

Sponsor / Collaborator

Instituto de Investigación Hospital Universitario La Paz

[+1]

NCT06265584 / Not yet recruitingPhase 2IIT

Phase II Clinical Trial of 2 Step ATG Combined with Tacrolimus and Mini Methotrexate for Prevention of Acute GVHD Post Reduced Intensity Allogeneic Stem Cell Transplant

In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion, leading to better immune reconstitution. Preliminary data where 80% of the ATG dose is given on days -6,-5,-4 and 20% given on day -1, showed effective prevention of severe acute GVHD, chronic GVHD and favorable early immune reconstitution. We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate can prevent grade III-IV acute GVHD and chronic GVHD, resulting in improvement of GVHD/relapse free survival at one year post transplant.

Start Date31 Jan 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

100 Clinical Results associated with Tacrolimus

100 Translational Medicine associated with Tacrolimus

100 Patents (Medical) associated with Tacrolimus

22,703

Literatures (Medical) associated with Tacrolimus

01 Jul 2025·Neural Regeneration Research

FK506 contributes to peripheral nerve regeneration by inhibiting neuroinflammatory responses and promoting neuron survival.

Article

Author: Xie, Wenyong ; Yuan, Yusong ; Han, Na ; Kou, Yuhui ; Ma, Bo ; Jin, Zongxue

JOURNAL/nrgr/04.03/01300535-202507000-00031/figure1/v/2024-09-09T124005Z/r/image-tiff FK506 (Tacrolimus) is a systemic immunosuppressant approved by the U.S. Food and Drug Administration. FK506 has been shown to promote peripheral nerve regeneration, however, its precise mechanism of action and its pathways remain unclear. In this study, we established a rat model of sciatic nerve injury and found that FK506 improved the morphology of the injured sciatic nerve, increased the numbers of motor and sensory neurons, reduced inflammatory responses, markedly improved the conduction function of the injured nerve, and promoted motor function recovery. These findings suggest that FK506 promotes peripheral nerve structure recovery and functional regeneration by reducing the intensity of inflammation after neuronal injury and increasing the number of surviving neurons.

01 Mar 2025·JOURNAL OF PEDIATRIC SURGERY

Intra-peritoneal Povidone-iodine Irrigation Decreases Abscesses in a Perforated Appendicitis Murine Model

Article

Author: Dassinger, Melvin S ; Wolf, Lindsey L ; Waldrip, Zachary ; Krinock, Derek J ; Stephenson, Krista ; Barker, Melanie ; Burdine, Marie ; Akmyradov, Chary ; Wyrick, Deidre ; Irby, David

BACKGROUND:

Children with perforated appendicitis frequently form post-operative intra-abdominal abscesses (IAA). Intra-peritoneal irrigation for prevention remains controversial. Using a perforated appendicitis murine model, we sought to determine the effect of intra-peritoneal irrigation on post-operative IAA and adhesion formation.

METHODS:

A survival operation was performed where cecal ligation and puncture was used to simulate perforated appendicitis. After 72 h, mice underwent a second operation where a distal cecectomy and intra-peritoneal irrigation was performed. Mice were assigned to a no irrigation group or one of four irrigation groups: normal saline, povidone-iodine (PVI), tacrolimus, or PVI followed by tacrolimus. At 2-weeks or 2-months after the second survival operation, mice were euthanized and IAAs were counted, measured, and cultured. Intra-peritoneal adhesion severity was graded on a 4-point scale. Statistical analysis compared IAA numbers and adhesion grade between the irrigation groups.

RESULTS:

In the 2-week cohort, prevalence of IAA was 78 % (n = 129). Type of irrigation solution was associated with abscess development (p < 0.001). Pairwise comparisons demonstrated PVI alone decreased abscess count. PVI irrigation caused more severe adhesions while tacrolimus decreased adhesions and adhesion grade was dependent on irrigation solution (p < 0.001). In the 2-month cohort, similar responses were observed with decreased abscess numbers in the PVI group (p = 0.006) but increased adhesion burden (p = 0.002).

CONCLUSION:

Povidone-iodine irrigation decreases intra-abdominal abscess formation, but increases adhesion formation.

LEVEL OF EVIDENCE: 1:

01 Mar 2025·Journal of Clinical and Experimental Hepatology

Sublingual Administration of Tacrolimus is Safe and Provides Similar Drug Exposure to Per-oral Route in Liver Transplant Recipients During Early Postoperative Period–A Large, Retrospective, Observational Study

Article

Author: Subramaniyam, Rekha ; Lohia, Pankaj ; Wadhawan, Manav ; Jamir, Imtiakum ; Sood, Gaurav ; Gupta, Anish ; Chaudhary, Abhideep ; Shriya, Aditya ; Soni, Hitesh ; Kumar, Niteen

Background/Aims:

Per-oral (PO) administration of tacrolimus (TAC) results in inadequate trough levels in the early postoperative period in liver-transplant (LT) recipients who undergo Roux-en-Y hepaticojejunostomy for biliary reconstruction. Sublingual administration (SL) of tacrolimus provides an alternative route in such patients.The objectives of this study were to assess the feasibility and safety of SL tacrolimus in adult LT-recipients in the early postoperative period and to compare therapeutic efficacy of SL administration of tacrolimus versus PO route.

Methods:

single-center, retrospective, observational study carried out in adult living donor liver transplant (LDLT) recipients between January 2022 and December 2022. Recipients who underwent Roux-en-Y hepaticojejunostomy for biliary reconstruction received tacrolimus through the SL route till postoperative day (POD) 5 as they were kept nil per oral constituted the study group while recipients who underwent duct-to-duct (D-D) anastomosis for biliary reconstruction were allowed orally from POD1 and received PO-tacrolimus were chosen as controls. The feasibility and safety of SL-tacrolimus were assessed in terms of patient acceptance, need to discontinue SL-tacrolimus, incidence of local adverse effects, and systemic adverse events like neurotoxicity and nephrotoxicity. Therapeutic efficacy was evaluated by comparing median trough levels (TAC level) achieved and incidence of graft rejection between two groups.

Results:

Two hundred twelve patients underwent LT during the study period, of which 125 were included (58 in the SL-group and 67 in PO-group). Both groups had comparable baseline characteristics. In the SL-group, all patients tolerated SL-Tacrolimus well and no local adverse events were observed. Patients with SL-Tacrolimus administration achieved a higher median TAC level (ng/ml) vs. PO route (5.85 vs. 5 (P = 0.06)) despite receiving similar median cumulative tacrolimus dose before assessing TAC-level. Fifty percent of patients achieved TAC level ≥6 ng/ml in SL-group vs. 35.8% in PO-group (P = 0.14). The incidence of neurotoxicity, nephrotoxicity, and graft rejection during hospital stay were similar in both the groups (P = 0.56, 0.82, and 0.28, respectively).

Conclusion:

SL-tacrolimus is safe and provides similar trough levels to PO-tacrolimus and may be considered as a viable alternative whenever inadequate TAC levels are anticipated through the per-oral route.

190

News (Medical) associated with Tacrolimus

09 Dec 2024

·www.businesswire.com

Orca Bio Presents Three-Year Survival Data with Orca-T® in Patients with Hematological Malignancies at the 66th ASH Annual Meeting

MENLO PARK, Calif.--( BUSINESS WIRE )--Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today presented positive long-term data on its lead investigational allogeneic T-cell immunotherapy, Orca-T, at the 66th American Society of Hematology (ASH) Annual Meeting. Three-Year Survival Data with Orca-T vs PTCy 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). These results also showed an improvement when compared to a historical cohort of patients receiving an allogeneic stem cell transplant (alloHSCT) with post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis. “With the current standard of care, physicians must carefully balance the risk of relapse with the risk of toxicities when treating patients with serious hematological malignancies, as both impact overall survival,” said presenting author Caspian Oliai, MD, medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center. “The preliminary results with Orca-T have been promising, and now observational outcomes show sustained improvement in comparison to a similar cohort of patients who received a conventional alloHSCT with PTCy at one, two and three years. These data add to the growing body of evidence suggesting Orca-T could potentially offer an important new treatment option for patients.” This analysis from the multicenter Phase 1b clinical trial evaluated a subset of patients (n=77) who received Orca-T with TAC. These outcomes were compared to patients from a CIBMTR literature-based cohort (n=293) who received alloHSCT with a PTCy-based GvHD prophylaxis regimen. All patients across both groups received myeloablative conditioning (MAC) and used a related or unrelated fully matched donor. These subsets of patients were selected based on disease, disease status and conditioning regimens that most closely resemble the patients enrolled in the ongoing pivotal Phase 3 clinical trial evaluating Orca-T. The analysis included patients who had a median follow-up time of 33 months (range 5-54 months) and 24 months (range 0-53 months) in the Orca-T Phase 1b and PTCy cohorts, respectively. The OS at 12, 24 and 36 months (p=0.0021) are summarized in the table below: Follow-up Phase 1b Orca-T plus TAC OS AlloHSCT with PTCy OS 1 year 96% (range 88%-99%; 95% CI) 82% (range 78%-87%; 95% CI) 2 year 88% (range 78%-94%; 95% CI) 73% (range 68%-79%; 95% CI) 3 year 86% (range 73-92%; 95% CI) 67% (range 61%-74%; 95% CI) Further analyses of these patient subsets found Orca-T may reduce non-relapse mortality (NRM) and increase relapse-free survival (RFS) compared to PTCy. At one year, NRM was 1.4% in the Orca-T group and 7.4% in the PTCy cohort. The rate of RFS at one year was 83% and 71% for patients receiving Orca-T and PTCy, respectively. Results also found that age had no significant impact on OS at one year. For patients receiving Orca-T, OS was 95% (88%-100%) in patients under the age of 50 and 97% (92%-100%) in patients over the age of 50. For patients in the PTCy cohort, OS was 86% (81%-92%) in patients under the age of 50 and 77% (70%-85%) in patients over the age of 50. Across all patients in the Phase 1b trial, Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S. “We’re pleased to present positive long-term follow-up data for Orca-T as these findings provide valuable insight into how the cell therapy performs over extended periods of time,” said Scott McClellan, MD, PhD, chief medical officer at Orca Bio. “As we eagerly await the results of our pivotal Phase 3 clinical trial evaluating Orca-T in a similar patient population, we are one step closer to gathering the information needed for BLA submission and toward potentially making a significant difference for patients.” Combining Orca Bio Approach with CAR-T Technology A second oral presentation highlighted initial feasibility, safety and efficacy data from an investigator-sponsored Phase 1 clinical trial evaluating OrCAR-T, a platform that combines the Orca Bio technology with CAR-T technology. This presentation highlighted data following treatment with Orca-T and allogeneic CD19/CD22 CAR-T cells in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL). B-ALL remains incurable for many patients despite treatment with an alloHSCT or autologous CAR-T cells, which can also lead to serious complications including GvHD, infections and CAR-related toxicities. Preliminary results for 10 patients treated with OrCAR-T who reached the primary endpoint of 42 days post-treatment showed neutrophil and platelet engraftment at 14 days. At a median follow up of 381 days (range 61-762 days, including 6 patients with >12 months of follow-up) across three dose escalation levels (1x10 6 CAR+ cells/kg; 2x10 6 CAR+ cells/kg; 3x10 6 CAR+ cells/kg), there were no cases of acute or chronic GvHD, no grade 3 or greater cytokine release syndrome and no neurotoxicity observed. These early findings suggest a single treatment that combines a high-precision cell therapy like Orca-T with specific CAR-T cells has the potential to benefit patients with a range of hematologic diseases. About Orca-T Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T is comprised of highly purified regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in Precision-T, a pivotal Phase 3 clinical trial, which has completed enrollment at leading transplant centers across the U.S. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. About Orca Bio Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer and autoimmune diseases. Our investigational products are designed to replace a patient’s diseased blood and immune system with a healthy one, with the goal of improving outcomes with fewer risks than the standard of care. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to transform allogeneic cell therapy. At Orca Bio, our mission is to make curative cell therapies both more effective and safer, and in doing so, push past the field’s current boundaries and redefine its future. For more information, visit www.orcabio.com .

Clinical ResultCell TherapyPhase 3ImmunotherapyPhase 1

03 Dec 2024

·www.prnewswire.com

InsightRX to Present Latest Research and Platform Enhancements at ASHP 2024 Midyear

SAN FRANCISCO, Dec. 3, 2024 /PRNewswire/ -- InsightRX – the leader in Bayesian model-informed precision dosing (MIPD) software – today announced it will attend the ASHP 2024 Midyear Clinical Meeting & Exhibition as both an exhibitor and presenter. The meeting is scheduled for Dec. 8-12 at the Ernest N. Morial Convention Center in New Orleans. ASHP 2024 is organized by the American Society of Health-System Pharmacists and will include vendor exhibits, educational sessions, poster presentations, and networking opportunities for pharmacy professionals. Representatives from the InsightRX team will be at booth 1340 in the exhibition hall (available on Monday Dec 9 and Tuesday Dec 10 from 11am - 3pm, and Wed Dec 11 from 11am - 2pm) to meet with visitors and discuss product updates, new features, and benefits of Bayesian MIPD adoption. Additionally, InsightRX Senior Director of Product & Customer Experience Jonathan Faldasz, PharmD, BCPS, will present a poster from the InsightRX team on Monday, Dec. 9, from 2-3:30 p.m. The title of the poster is Proposed Update to the Cockcroft-Gault Equation for Patients with Low Serum Creatinine: Results from a Massive Multi-Site Dataset. This study evaluated the accuracy of the Cockcroft-Gault equation–long regarded as the gold standard for estimating renal function–in patients with serum creatinine levels below 1 mg/dL. By analyzing data from nearly 100,000 patients, the InsightRX team identified significant inaccuracies in the equation's predictions for this population. In response, they developed a modified equation incorporating adjusted serum creatinine, which demonstrated greatly improved accuracy. The poster will detail these findings and their implications for clinical practice. Front and center will be demonstrations of a new feature to the Nova platform, InsightRX Gemini, designed to eliminate complexities of manual PK model selection. InsightRX Gemini automatically chooses the best-performing PK model for the patient, based on four common covariates, and was built analyzing approximately 400,000 vancomycin treatment courses contained in the Nova data lake. When compared to commonly available PK models (seen in "freeware" and various other applications), InsightRX Gemini: increases dosing accuracy for individual patients up to 47.2% increases precision by up to 25% decreases bias by up to 93% Overall, MIPD dosing activities have increased for a variety of therapeutic areas and hold promise for enhancing workflows and producing more accurate dosing and improved outcomes. In addition to vancomycin, InsightRX offers numerous other Drug Modules, which the team will also present at the exhibition. Several of these were highlighted in recent studies, thought leadership articles, and blog posts by the InsightRX team over the past year, including: Antifungals – Posaconazole is a pharmacotherapeutic pillar for prophylaxis and treatment of invasive fungal diseases. Dose individualization is critical to achieving adequate antifungal exposure associated with improved outcome. InsightRX validated an MIPD strategy for posaconazole for its fit-for-purpose, an important first step toward dosage optimization with the goal to improve antifungal treatment in clinical practice. Beta-lactams – Therapeutic drug monitoring (TDM) can improve PK/PD target attainment of beta-lactam levels and optimize dosing in vulnerable populations. There are still several barriers to widespread adoption of TDM of beta-lactams into routine clinical practice, however, beta-lactam TDM has great potential to improve patient care by optimizing antibiotic dosing, especially in high-risk populations. Solid organ transplant – Therapeutic drug monitoring is essential with tacrolimus, one of the key immunosuppressive agents used after solid organ transplant. Although most transplant centers rely on trough concentrations drawn immediately before the dose, evidence shows a poor correlation between tacrolimus trough concentrations and outcomes. A 2019 tacrolimus guidance document concludes that Bayesian estimation may be a better way to improve future tacrolimus TDM. Bone marrow transplant – Dose personalization improves patient outcomes for many drugs with a narrow therapeutic index and high inter-individuality variability, including busulfan. In a simulated study, InsightRX demonstrated that while area under the curve (AUC) estimates between the two methods showed good correlation, the maximum a posteriori Bayesian (MAP) approach led to higher target attainment for busulfan dosing. Anticoagulants – Heparin is a lifesaving mainstay of anticoagulation in patients at high risk of coagulation-related morbidity and mortality. Yet most hospitals struggle to keep their patients at a target heparin exposure, which can result in increased morbidity and mortality from both clotting and bleeding events. Several exciting advances in the use of MIPD for heparin would allow clinicians to better individualize therapy for each treatment course. Inflammatory bowel disease – Efficacy of infliximab in children with inflammatory bowel disease can be enhanced when serum concentrations are measured and further dosing is adjusted to achieve and maintain a target concentration. A recent collaborative study showed that a population pharmacokinetic model may help to predict an individual's infliximab dose requirement. "InsightRX has enjoyed a year of real growth and accomplishment and we're excited to meet with our colleagues at ASHP in New Orleans to discuss what we've learned and how we plan to continue improving dosing safety and accuracy," said Sirj Goswami, PhD, CEO and cofounder of InsightRX. "Model-informed precision dosing holds great promise for contributing to better clinical outcomes and operational efficiency." About InsightRX InsightRX is a healthcare technology company providing a cloud-based clinical decision support platform that applies quantitative pharmacology and AI to enhance therapeutic decision-making from phase I drug development to point of care. The company's platform provides an individualized, predictive understanding of a patient's response to treatment which enables an enhanced understanding of dose-effect response and toxicity for clinicians to improve medication effectiveness. Media Contact Michelle Noteboom Amendola Communications for InsightRX [email protected] SOURCE InsightRX WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

03 Dec 2024

·www.globenewswire.com

Lipella Pharmaceuticals Announces Publication in CUREUS on Non-Steroid Treatment of Oral Lichen Planus

Peer-reviewed article highlights potential treatment for OLP with focus on localized drug deliveryPITTSBURGH, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company dedicated to addressing serious diseases with significant unmet needs, today announced the publication of a peer-reviewed paper in CUREUS. Titled “Rationale for the Use of Topical Calcineurin Inhibitors in the Management of Oral Lichen Planus and Mucosal Inflammatory Diseases,” the paper focuses on non-steroid treatments for oral lichen planus (OLP), particularly topical calcineurin inhibitors (TCIs) such as tacrolimus. TCIs are non-steroidal medications used to treat inflammatory and autoimmune conditions by targeting the enzyme calcineurin, critical for T-cell activation and cytokine production. The publication also explores advanced drug delivery systems designed to address the challenges of treating chronic inflammatory conditions like OLP. The paper emphasizes the potential of Lipella’s investigational therapy, LP-310, a novel oral rinse formulation of LP-10 (tacrolimus) specifically designed to provide localized therapeutic effects for OLP while minimizing systemic exposure. LP-310 is currently being evaluated in a Phase 2a multicenter clinical trial focused on safety, tolerability, and efficacy in adult patients with symptomatic OLP. Dr. Michael Chancellor, Lipella’s Chief Medical Officer and author of the paper, commented, “Oral lichen planus is a chronic inflammatory condition that significantly impacts patients' quality of life. Traditional therapies, primarily topical corticosteroids, often lead to undesirable side effects with long-term use. Our research emphasizes the promise of TCIs, such as tacrolimus, as effective alternatives that may offer a steroid-sparing approach. This peer-reviewed paper represents an important next step in advancing a potential breakthrough treatment option for OLP, aiming to address the unmet needs of patients with this challenging condition.” The publication details the underlying mechanisms of OLP, the role of TCIs in treatment, and emerging therapies such as topical liposomal formulation of tacrolimus designed to optimize local drug delivery while reducing systemic exposure. About Oral Lichen Planus (OLP) Oral Lichen Planus (OLP) is a chronic inflammatory condition that affects the mucous membranes inside the mouth, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue and open sores, OLP impacts approximately 6 million Americans and currently has no FDA-approved therapies. About LP-310 LP-310 is an innovative oral rinse formulation of LP-10 (tacrolimus), developed to address oral lichen planus. Designed to provide localized therapeutic effects while minimizing systemic exposure, LP-310 offers a promising new approach to managing this painful and often debilitating condition. A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites, which are now recruiting participants. Top-line data is anticipated by the end of 2024, with the trial expected to conclude by mid-2025. For more information about the study or to participate, visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591. About Lipella Pharmaceuticals Inc.Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. Forward-Looking StatementsThis press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as "may," "will," "could," "continue," "would," "should," "potential," "target," "goal," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "predicts," "expects," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the effective application of the use of proceeds from the private placement, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein. CONTACTJonathan KaufmanChief Executive OfficerLipella Pharmaceuticals Inc. Info@Lipella.com 1-412-894-1853 PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com

Phase 2Drug Approval

100 Deals associated with Tacrolimus

External Link

KEGG	Wiki	ATC	Drug Bank
D08556	Tacrolimus	L04AD02 D11AH01	DB00864

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Vernal Keratoconjunctivitis	KR	Taejoon Pharm Co. Ltd.	11 Jul 2019
Lung Diseases, Interstitial	JP	Astellas Pharma, Inc.	14 Jun 2013
Small intestine transplantation rejection	JP	Astellas Pharma, Inc.	26 Jul 2011
Colitis, Ulcerative	JP	Astellas Pharma, Inc.	07 Jul 2009
Mucositis	JP	Senju Pharmaceutical Co., Ltd.	25 Jan 2008
Allograft Rejection	EU	Astellas Pharma Europe BV	23 Apr 2007
Allograft Rejection	IS	Astellas Pharma Europe BV	23 Apr 2007
Allograft Rejection	LI	Astellas Pharma Europe BV	23 Apr 2007
Allograft Rejection	NO	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	EU	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	IS	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	LI	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	NO	Astellas Pharma Europe BV	23 Apr 2007
Lupus Nephritis	JP	Astellas Pharma, Inc.	26 Jan 2007
Rejection of pancreas transplant	JP	Astellas Pharma, Inc.	19 Jan 2005
Lung transplant rejection	JP	Astellas Pharma, Inc.	31 Jan 2003
Cardiac transplant rejection	JP	Astellas Pharma, Inc.	20 Jun 2001
Myasthenia Gravis	JP	Astellas Pharma, Inc.	20 Sep 2000
Dermatitis, Atopic	JP	Maruho Co., Ltd.	16 Jun 1999
Bone marrow transplant rejection	JP	Astellas Pharma, Inc.	30 Apr 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	US	Veloxis Pharmaceuticals A/S	28 Mar 2019
Renal and pancreas transplant rejection	Phase 3	US	Veloxis Pharmaceuticals A/S	27 Feb 2019
Tremor	Phase 3	US	Veloxis Pharmaceuticals A/S	01 Dec 2011
Kidney Diseases	Phase 3	AR	Astellas Pharma, Inc.	30 Sep 2009
Kidney Diseases	Phase 3	AT	Astellas Pharma, Inc.	30 Sep 2009
Kidney Diseases	Phase 3	BY	Astellas Pharma, Inc.	30 Sep 2009
Kidney Diseases	Phase 3	BE	Astellas Pharma, Inc.	30 Sep 2009
Kidney Diseases	Phase 3	BR	Astellas Pharma, Inc.	30 Sep 2009
Kidney Diseases	Phase 3	CA	Astellas Pharma, Inc.	30 Sep 2009
Kidney Diseases	Phase 3	CO	Astellas Pharma, Inc.	30 Sep 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04339101 (1043, ASH2024)	Phase 2	Myelofibrosis \| acute leukemia \| Myelodysplastic Syndromes HGF \| IL17 \| TNFaR ... View more	59	Itacitinib + Tacrolimus/Sirolimus	atexcvvyxs(mnfyiodnng) = iawxmtqupg cixcxrkmnn (kkfrcxdacj, 41 - 66) View more	Positive	09 Dec 2024
				Tacrolimus/Sirolimus	atexcvvyxs(mnfyiodnng) = dpxunprjmh cixcxrkmnn (kkfrcxdacj )
ASH2024	Not Applicable	Hematopoietic stem cell transplantation	-	Tacrolimus/Methotrexate	tqzphdfodf(bstqtdfpdv) = ivaygvmppu rurwpagrvr (ywlveguttn, 15.9) View more	-	07 Dec 2024
				Post-Transplant Cyclophosphamide	tqzphdfodf(bstqtdfpdv) = rutsmmfcta rurwpagrvr (ywlveguttn, 9.9) View more
NCT02880293 (CTgov)	Not Applicable	Hematologic Neoplasms	44	Mesna+Fludarabine+cyclophosphamide+melphalan+Filgrastim+Tacrolimus+Mycophenolate Mofetil+thiotepa	merhgjcxbj(umvipekylv) = yayolpzbss lqlaubdqhb (qhtigaehia, adufudpeet - fzqmlkbotw) View more	-	06 Dec 2024
NCT02582775 (CTgov)	Phase 2	Epidermolysis Bullosa	17	Donor mesenchymal stem cell infusions+Fludarabine+Cyclophosphamide+Thymoglobulin+Tacrolimus+mycophenolate mofetil (RDEB: HCT Plus MSC Arm B)	vjuyfkoxgo(ewpgodzrcs) = iutzeamdtj lohtmjlsuv (vzkmtirgbz, cdxdnhxrts - requaijhlt) View more	-	19 Sep 2024
				Donor mesenchymal stem cell infusions+Fludarabine+Cyclophosphamide+Thymoglobulin+Tacrolimus+mycophenolate mofetil (RDEB: HCT Plus MSC Arm E)	vjuyfkoxgo(ewpgodzrcs) = cdbtfcgtkl lohtmjlsuv (vzkmtirgbz, afeevsjtbr - afmmixzlay) View more
NCT05501574 (GlobeNewswire) Manual	Phase 2	Lung transplant rejection	13	TFF TAC	agmzpplsgl(hjkseuqngg) = No signs or symptoms suggestive of acute rejection. No use of pulse corticosteroids for treatment of rejection. No spirometry deterioration suggestive of acute rejection. No chest x-ray findings suggestive of acute rejection. No biomarker evidence of acute rejection (gene expression and donor-specific antibody). zhkvnvzsnj (hvymefgila ) View more	Positive	06 Aug 2024
NCT03480360 (CTgov)	Phase 3	Acute Myeloid Leukemia \| Chronic phase chronic myeloid leukemia \| Chronic Lymphocytic Leukemia ... View more	21	G-CSF+Fludarabine+cyclophosphamide+Tacrolimus+cellcept	ittytgavfa(dhphobpdgm) = zkwmtskesv wmuzmicbkg (bkippnarws, csyahkddpm - pslwwvnlam) View more	-	23 Jul 2024
NCT03511560 (CTgov)	Phase 4	Renal transplant rejection	50	Tacrolimus (Tacrolimus, Immediate Release)	rfoadadkdg(spkewxqqie) = kzwvkujeqx gvjurxilma (fgmhzcnjyw, irsoygqmma - ibkzuzflut) View more	-	17 Jul 2024
				Tacrolimus Extended Release Oral Tablet (Envarsus XR)	rfoadadkdg(spkewxqqie) = lqrvazaxud gvjurxilma (fgmhzcnjyw, kjwptlhzps - osutveaypn) View more
NCT04225988 (CTgov)	Phase 4	Renal transplant rejection	20	Extended-release tacrolimus (Extended-release Tacrolimus)	uubhaqbqjp(kkbnsiiouw) = ffmsiglkmc reikgnntcm (pmdfbcopoa, kmroszlvkt - igycfwhric) View more	-	10 Jul 2024
				Immediate-release tacrolimus (Immediate-release Tacrolimus)	uubhaqbqjp(kkbnsiiouw) = kogrlshccd reikgnntcm (pmdfbcopoa, tqeagmqjeg - bygvccrenf) View more
NCT03823768 (CTgov)	Phase 4	Neurotoxicity Syndromes \| Liver transplant rejection	30	Tacrolimus Immediate release (Arm 1: Control)	jbgsebxoki(vjvuijpxyb) = xjapwklfqb fevpnfeavw (qcdyhvgpem, guzkzginfw - ejxvlgmwzd) View more	-	27 Jun 2024
				Envarsus (Arm 2: Intervention)	jbgsebxoki(vjvuijpxyb) = rpkvoyxtzj fevpnfeavw (qcdyhvgpem, iztbswxvrl - bapdervvey) View more
EULAR2024	Not Applicable	Lung Diseases, Interstitial anti-MDA5 antibody	24	Tacrolimus-based triple-combination therapy	lhtatuzyzd(morggfubpi) = ejfkdghozo psruqhdxha (airmhroxdd )	Positive	05 Jun 2024
				Ciclosporin-based triple-combination therapy	yxcchqyriu(vneeoirysr) = nhbvwckntp wngpnbtnpv (ktivfssmfj, -5 to 45) View more

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