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Last update 01 Jun 2026

Tacrolimus

Last update 01 Jun 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Molecular glue

Synonyms

Inhaled tacrolimus, mdc-GRT, Nano-Tacrolimus

+ [61]

Target

CaN

Action

inhibitors

Mechanism

CaN inhibitors(Calcineurin inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [11]

Active Indication

Vernal KeratoconjunctivitisLung Diseases, InterstitialSmall intestine transplantation rejection+ [80]

Inactive Indication

Acute Chest SyndromeAcute Graft Versus Host DiseaseAcute myeloid leukaemia with 11q23 abnormality+ [125]

Originator Organization

Astellas Pharma, Inc.

Active Organization

City of Hope National Medical Center

Fred Hutchinson Cancer Research Center

CHIESI Farmaceutici SpA

+ [25]

Inactive Organization

The University of California, San Francisco

Novartis Pharmaceuticals Corp.

Biodexa Pharmaceuticals Plc

+ [21]

License Organization

Aequus Pharmaceuticals, Inc.

Veloxis Pharmaceuticals A/S

Taiba Pharma

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (08 Apr 1994),

Graft Rejection

RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea)

Structure/Sequence

Molecular FormulaC44H71NO13

InChIKeyNWJQLQGQZSIBAF-MLAUYUEBSA-N

CAS Registry109581-93-3

1,470

Clinical Trials associated with Tacrolimus

NCT07582172

/ Not yet recruitingPhase 2IIT

Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS

This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and/or effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.

Start Date05 Apr 2027

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06084780

/ Not yet recruitingPhase 2IIT

Prospective Case Series of Intestinal and Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

The goal of this prospective phase 2 study is to assess the efficacy and safety of intestinal or multivisceral transplantation for participants with PMP not amenable to other curative-intent treatments. Participants will undergo intestinal/multivisceral transplantation. Participants will be followed for 12 months to assess efficacy and safety.

Start Date01 Aug 2026

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT07524530

/ Not yet recruitingPhase 2IIT

Phase II Haploidentical Hematopoietic Stem Cell Transplantation for Participants With Germline RUNX1 Associated Hematologic Malignancies

Background:
Some blood cancers can be caused by germline variants (changes) in a person s RUNX1 gene. Germline variants are genetic inherited changes a person is born with. Stem cell transplants are used to treat many diseases including blood cancers. Stem cell transplantation for patients with germline RUNX1 mutation driven blood cancers is standard of care and available in most major medical centers. The difference with this transplantation protocol is that it is prospective, only available to participants with germline RUNX1 variants and designed to determine the extent to which tailoring chemotherapy and supportive care medication doses for each individual patient may improve outcomes compared to data derived from retrospective transplantation protocols for patients with RUNX1 varinats which is less accurate.
Objective:
The primary objective of this protocol is to determine how tailored doses of chemotherapy and supportive care medications may improve disease free survival as compared to historical/expected disease free survival.
Eligibility:
People aged 4 to 70 years with blood cancer caused by a RUNX1 gene mutation. Other participants are also needed: (1) stem cell donors; (2) relatives who do not have a mutation in the RUNX1 gene; and (3) healthy volunteers.
Design:
Participants with blood cancer will be screened during approximately 1-3 months before transplatation. They will have blood tests and tests of their heart and lung function. A sample of bone marrow may be taken.
A flexible tube (central line) will be inserted into a vein in participants chest or lower neck. This line will remain in place during the hospitalization and be used to draw blood and administer drugs. These lines are almost always transitioned to a peripherally inserted central catheter (PICC) line at the time of hospital discharge.
Participants will be inpatient for 4 to 5 weeks. They will receive drugs to prepare their body for the stem cell transplant. Some may also receive radiation treatment. Other tests will include imaging scans. The stem cell transplant will be given through the central line.
After discharge from the clinic, participants will have follow-up visits at least once per week for approximately 100 days. Then they will have follow-up clinic visits for 3 years.
Donors, relatives, and healthy volunteers may provide samples of blood, stool, and saliva. Adults may also opt to provide samples of skin and bone marrow.

Start Date04 Jun 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Tacrolimus

100 Translational Medicine associated with Tacrolimus

100 Patents (Medical) associated with Tacrolimus

28,299

Literatures (Medical) associated with Tacrolimus

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Maintenance management after dupilumab discontinuation in moderate-to-severe atopic dermatitis: a comparative study of proactive intermittent tacrolimus and reactive rescue therapy

Article

Author: Li, Zaibing ; Tang, Yan

BACKGROUND:

Moderate-to-severe atopic dermatitis (AD) often relapses after dupilumab discontinuation. This study compared proactive intermittent tacrolimus versus on-demand therapy for post-discontinuation maintenance.

METHODS:

This was a real-world, mixed retrospective-prospective observational study conducted at a single dermatology center. Patients who discontinued dupilumab were identified through retrospective chart review, and a subset was followed prospectively. Based on observed post-discontinuation topical management patterns, patients were classified into a proactive maintenance group or a reactive, as-needed treatment group. Patients were followed for 24 weeks, with extended follow-up to 52 weeks for exploratory analyses. The primary outcome was time to first flare.

RESULTS:

Median follow-up was 28 weeks. Proactive maintenance prolonged flare-free survival (HR 0.62, 95% CI 0.45-0.86, p = 0.004), reduced flare rate (IRR 0.68, 95% CI 0.52-0.88, p = 0.003), and lowered steroid use (mean difference -18.4 g, p < 0.001). PROs improved more (POEM β -2.1; DLQI β -1.8). Local reactions were comparable (8.3 vs. 7.9%); no serious adverse events occurred.

CONCLUSION:

Proactive intermittent tacrolimus after dupilumab reduces flare risk and steroid burden, improving outcomes, and is a feasible maintenance strategy.

31 Dec 2026·ANNALS OF MEDICINE

Genetic and clinical determinants of tacrolimus accumulation in early liver transplantation: evidence for a combined genotype-antibiotic effect

Article

Author: Feng, Zifan ; Cai, Xinfeng ; Feng, Shiying ; Zhang, Rui ; Guo, Jinlin ; Li, Xingang ; Yang, Jinyan

BACKGROUND:

Tacrolimus is a first-line immunosuppressant essential for preventing graft rejection after liver transplantation, but its narrow therapeutic index and extensive interindividual pharmacokinetic variability complicate optimal dosing during the early postoperative phase.

METHODS:

The pharmacokinetics of tacrolimus were analyzed in liver transplant recipients from longitudinal trough concentrations collected within the first 30 days of administration using non-compartmental models. Associations between pharmacokinetic indices and covariates were assessed using Spearman's correlation, t-tests, ANOVA, Wilcoxon rank-sum, or Kruskal-Wallis tests, and genotype-drug combined effects by ANOVA. Protein models were generated by ColabFold and docked with drugs using CB-Dock2. Machine-learning models predicted pharmacokinetic parameters.

RESULTS:

Tacrolimus trough accumulation dynamics showed interindividual variability, with the time to maximum trough concentration (t(C0,max)) ranging across patients. The ABCB1 rs2032582 AC genotype in recipients was associated with earlier t(C0,max) and greater accumulation, while donor CYP3A4 rs4646437 was linked to differences in a trough accumulation index. Cefoperazone/sulbactam administration was associated with more pronounced trough accumulation and shorter t(C0,max), and a combined genotype-antibiotic effect was observed, whereby rs2032582 AC carriers receiving cefoperazone/sulbactam reached peak trough levels earlier. Docking analyses suggested that cefoperazone may competitively bind ABCB1 at sites overlapping tacrolimus binding, particularly in the rs2032582 AC variant. Multiple biomarkers for liver function, coagulation, and hematologic indices were associated with pharmacokinetic metrics, findings supported by machine-learning models.

CONCLUSIONS:

These findings highlight a combined effect of genetic background and antibiotic use on tacrolimus trough exposure dynamics, providing mechanistic insight that may inform individualized monitoring and dosing in the early phase after liver transplantation.

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Efficacy of topical tacrolimus for oral lichen planus: a retrospective cohort study stratified by cutaneous involvement

Article

Author: Li, Shujia ; Weng, Siwei

BACKGROUND:

Oral lichen planus (OLP) is a chronic T-cell-mediated inflammatory mucocutaneous disorder with limited evidence on topical tacrolimus efficacy in subgroups based on cutaneous involvement.

METHODS:

This single-center retrospective cohort study analyzed data (2019-2024) from 120 biopsy-confirmed OLP patients after propensity score matching. Patients were classified according to treatment with topical tacrolimus 0.1% gel or clobetasol propionate 0.05% gel and stratified by cutaneous involvement. Primary outcomes included 8-week changes in visual analog scale (VAS) pain and total atrophic area (TAA), analyzed using mixed-effects models.

RESULTS:

Patients with cutaneous involvement exhibited higher baseline severity (p < 0.01). Tacrolimus use was associated with significant reductions in VAS (-1.2; 95% CI -1.7 to -0.7) and TAA (-1.0; 95% CI -1.4 to -0.6) compared to controls. The response rate was superior in the tacrolimus group (OR 3.2; 95% CI 1.5-6.8; p = 0.002). Notably, treatment effects were stronger in patients with cutaneous involvement (interaction p < 0.05). Adverse events were mild and transient; the most common event was burning sensation.

CONCLUSIONS:

Topical tacrolimus was associated with improved short-term OLP outcomes and may be particularly useful as a second-line or steroid-sparing option in patients with concomitant cutaneous involvement.

308

News (Medical) associated with Tacrolimus

29 May 2026

·www.everestmedicines.com

23 Abstracts on NEFECON® to Be Presented at the 63rd ERA Congress

Shanghai, China – May 29, 2026 – Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that 23 abstracts on NEFECON® (budesonide delayed-release capsules) have been accepted for presentation at the 63rd European Renal Association (ERA) Congress, including 11 oral presentations and 12 e-posters. The congress will take place in Glasgow, United Kingdom, from June 3 to 6, 2026. The newly released results from 21 real-world studies conducted in China further validate the efficacy and safety of NEFECON® in clinical practice and reinforce its position as a cornerstone of first-line treatment for patients with IgA nephropathy. Oral Presentation 01 Title：Real-World Impact of Nefecon Combined with Other lmmunosuppressants in Chinese IgAN Patients Main Author and Institution：Ying Fan, Shuling Chen，Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine Time：June 4, 2026，09:39-09:45 BST Location：Focussed Oral Room 5 02 Title：A Real-World Study of Efficacy and Safety of Nefecon in IgA Nephropathy Patients with Different Renal Function Stratifications Main Author and Institution：Ying Yang，The Second Hospital of Shanxi Medical University Time：June 4, 2026，11:33-11:39 BST Location：Focussed Oral Room 2 03 Title：Nefecon as Add-On Therapy in Refractory IgA Nephropathy: A Real-World Case Series Main Author and Institution：Sha Chen, Tianjin Hospital Time：June 4, 2026，16:06-16:12 BST Location：Focussed Oral Room 2 04 Title：Differential Renal Response to Nefecon in IgA Nephropathy: A Retrospective Study Stratified by Baseline eGFR Main Author and Institution：Fanna Liu，The First Affiliated Hospital of Jinan University Time：June 4, 2026，16:54-17:00 BST Location：Focussed Oral Room 3 05 Title：Real-World Analysis of Efficacy and Safety of Nefecon Combined with Low Dose Corticosteroids in High-Risk Progressive IgA Nephropathy Main Author and Institution：Xiaoling Zhou，General Hospital of Ningxia Medical University Time：June 4, 2026，17:21-17:27 BST Location：Focussed Oral Room 7 06 Title：Real-World Study on Efficacy and Safety of Nefecon in IgA Nephropathy Main Author and Institution：Xin Wei，Honghui Zeng，The First Affiliated Hospital of Nanchang University Time：June 4, 2026，09:21-09:27 BST Location：Focussed Oral Room 3 07 Title：Budesonide Combined with Mycophenolate Mofetil Enhances Response Rates in IgA Nephropathy: A Real-World Study Main Author and Institution：Xue Jiang, Hangzhou Traditional Chinese Medicine Hospital Time：June 4, 2026，09:21-09:27 BST Location：Focussed Oral Room 5 08 Title：Podocyte Hypertrophy Predicts Treatment Response to Targeted-Release Budesonide ± Tacrolimus in IgA Nephropathy: A Real-World Retrospective Study Main Author and Institution：Guiqing Tian，Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Time：June 4, 2026，16:06-16:12 BST Location：Focussed Oral Room 3 09 Title：A 15-Month Nefecon Therapy in IgA Nephropathy: A Propensity Score-Matched Study Main Author and Institution：Xiu Yang，The First People's Hospital of Hangzhou Time：June 4, 2026，11:21-11:27 BST Location：Focussed Oral Room 5 10 Title：NefIgArd: Efficacy of Nefecon in Immunoglobulin A Nephropathy Patients With a Baseline Urine Protein-Creatinine Ratio of 0.5 to 1g/gram Main Author and Institution：Jonathan Barratt，University of Leicester Time：June 4, 2026，11:27-11:39 BST Location：Lomond Auditorium 11 Title：NefIgArd: Assessment of Kidney Function With Nefecon Versus Placebo in Patients With Proteinuria or Hematuria Non-Response Main Author and Institution：Richard Lafayette，Stanford University Time：June 4, 2026，11:57-12:09 BST Location：Lomond Auditorium E-Poster 01 Title：Efficacy and Safety of Oral Budesonide Targeted-Release Formulation Combined with Ambrisentan in the Treatment of IgA Nephropathy Main Author and Institution：Weixia Sun，the First Hospital of Jilin University Changchun Location：Research Zone 02 Title：Real-World Study on the Efficacy and Safety of Combination Therapy of Nefecon and Hydroxychloroquine in the Treatment of IgA Nephropathy Main Author and Institution：Xin Wei，The First Affiliated Hospital of Nanchang University Location：Research Zone 03 Title：Efficacy and Safety of Nefecon Combined with Mycophenolate Mofetil in the Treatment of IgA Nephropathy: Real-World Data Main Author and Institution：Xin Wei，The First Affiliated Hospital of Nanchang University Location：Research Zone 04 Title：More treatment options: Real-world efficacy and safety of Nefecon with or without immunosuppression in patients with IgA nephropathy Main Author and Institution：Jing Li，The First Affiliated Hospital of Xinjiang Medical University Location：Research Zone 05 Title：Effectiveness and Safety of Nefecon Beyond Pivotal Trial Populations in IgA Nephropathy: 6-Month Real-World Main Author and Institution：Xingyang Zhao，Tongji Hospital, Huazhong University of Science and Technology Location：Research Zone 06 Title：Comparative Efficacy of Budesonide Enteric-Coated Capsules (Nefecon) in the Management of IgA Nephropathy Stratified by Baseline Proteinuria Levels Main Author and Institution：Jia Lv，The First Affliated Hospital of Xi’an Jiaotong University Location：Research Zone 07 Title：Efficacy of Nefecon in IgA Nephropathy Patients with 24-Hour Urine Protein Excretion of 0.5–1.0 g: A 9-Month Retrospective Study Main Author and Institution：Jun Cheng, The First Affiliated Hospital of Zhejiang University School of Medicine Location：Research Zone 08 Title：Real-World Data on Early Treatment of IgA Nephropathy Patients with Baseline Proteinuria of 0.5-1g/d Using Nefecon for 9 Months Main Author and Institution：Jing Li, First Affiliated Hospital of Xinjiang Medical University Location：Research Zone 09 Title：Impact of Early Diagnosis and Treatment on the Efficacy of Nefecon in Patients with IgA Nephropathy: A Single-Center Follow-Up Study Main Author and Institution：Yi Ren，Longhua Hospital Affiliated to Southern University of Science and Technology Location：Research Zone 10 Title：Early Initiation of Targeted-Release Budesonide in IgA Nephropathy: A Multi-Center Prospective Study Design and Baseline Characteristics Main Author and Institution：Yunlin Feng, Sichuan Provincial People’s Hospital Location：Research Zone 11 Title：Early Initiation of targeted-release budesonide in primary IgA nephropathy: a multicenter prospective study's baseline and interim analysis Main Author and Institution：Yunlin Feng, Sichuan Provincial People’s Hospital Location：Research Zone 12 Title：Beyond Twelve Months: Real-World Efficacy and Safety of Nefecon in Patients With Newly Diagnosed IgA Nephropathy Main Author and Institution：Wenjing Zhang，The First Affiliated Hospital of Xi’an Jiao Tong University Location：Research Zone About NEFECON® NEFECON® is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. NEFECON® was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-IgA1) causing IgA nephropathy. NEFECON® was approved in November 2023 through National Medical Products Administration (NMPA)’s priority review for the treatment of primary IgA nephropathy in adults at risk of disease progression. It was subsequently included in the National Reimbursement Drug List in November 2024, and received full approval from the NMPA in April 2025, irrespective of proteinuria levels, benefiting most individuals living with IgA nephropathy. It has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan region, China, as well as Singapore and South Korea. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies. he Company’s therapeutic areas of focus include CKM (cardiovascular, kidney, and metabolic), autoimmune, ophthalmology and critical care. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company’s website: www.everestmedicines.com. Forward-Looking Statements This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. References 1.Lafayette R,et al. Lancet. 2023 Sep 9;402(10405):859-870. 2. Zhang H, et al. Kidney360. 2024 Dec 1;5(12):1881-1892. 3.Jonathan Barratt,et al. 2023 ASN. Poster no. SA-PO886. 4.Edsbäcker S,et al. Aliment Pharmacol Ther. 1999 Feb;13(2):219-24.

Drug ApprovalClinical Study

18 May 2026

·www.biospace.com

New Peer-Reviewed Publication Confirms Unprecedented Response Rates for STRATA’s Excimer Laser Combined with JAK Inhibitors in Pediatric Vitiligo

Multicenter prospective RCT published in JAAD confirms superiority of XTRAC® Excimer Laser plus oral JAK inhibitors over tacrolimus combination therapy in children aged 2–18 years with progressive vitiligo, fueling continued market growth and expanding indications HORSHAM, Pa., May 18, 2026 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”), a global leader in excimer laser therapy dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, today highlighted the publication of a landmark multicenter, prospective, randomized controlled trial in the Journal of the American Academy of Dermatology demonstrating that STRATA’s 308-nm excimer laser, when combined with oral JAK inhibitors, produces unprecedented repigmentation outcomes in pediatric patients with progressive vitiligo — with a favorable safety pro all 188 children enrolled over a 48-week treatment period. The study, conducted across five leading academic dermatology centers in China, enrolled children aged 2–18 years and compared two treatment arms: oral JAK inhibitors (baricitinib or tofacitinib) combined with 308-nm excimer laser therapy twice weekly (Group A) versus topical tacrolimus combined with the same excimer laser protocol (Group B). KEY STUDY FINDINGS Overall response rate of 85.5% in the JAK inhibitor + excimer laser group versus 53.8% in the tacrolimus + excimer laser control group (P95% repigmentation by week 48, compared to only 3 in the control arm Mixed-effects modeling confirmed a statistically significant 21.7% higher repigmentation rate for the JAK inhibitor + excimer laser combination (β = 0.217, 95% CI: 0.204–0.230, P<.001) All adverse events were mild to moderate in severity and fully resolved with appropriate management; no cases of tuberculosis or hepatitis B/C were observed Quality of life improvements, measured by the Children’s Dermatology Life Quality Index, were significantly greater in Group A, reaching statistical significance by week 48 (P<.001) “This publication is a powerful validation of our personalized medicine approach and confirms what we have long believed — that the XTRAC ® excimer laser is not just a stand-alone therapy, but an essential, synergistic component of next-generation combination regimens. XTRAC ® - 308-nm excimer laser served as the phototherapy backbone for both arms, underscoring its central and indispensable role in modern vitiligo combination therapy. ” said Dr. Dolev Rafaeli, President and CEO of STRATA Skin Sciences. “The unprecedented response rates seen here in children — a historically underserved and difficult-to-treat population — reinforce the growing body of peer-reviewed evidence supporting the XTRAC ® platform as the cornerstone of modern vitiligo care . We are proud to see our technology driving outcomes that meaningfully improve patients’ lives.” The mechanistic basis for these results reflects the complementary action of both therapies: JAK inhibitors suppress the upstream IFN-γ/JAK-STAT1 autoimmune signaling cascade that drives melanocyte destruction, while the 308-nm excimer laser simultaneously induces targeted apoptosis of pathogenic T cells at the dermo epidermal junction and actively promotes melanocyte migration and repopulation within lesional skin. Together, these mechanisms address both the immunological and cellular dimensions of vitiligo in a true personalized medicine approach. Intellectual Property Portfolio STRATA’s growing portfolio of patent applications is designed to support intellectual property protection and potential market exclusivity for combination therapies involving its XTRAC ® excimer laser when used with JAK inhibitors, systemic agents, and biologic drugs. These pending or applied-for patents underpin STRATA’s strategy to expand into new clinical indications, including vitiligo and other inflammatory and autoimmune skin conditions. “It is important that we continue to grow our market by expanding into new indications, while maximizing revenue opportunities for the Company and our partner clinics,” said Dr. Dolev Rafaeli, President and Chief Executive Officer of STRATA Skin Sciences. “Foundational to this long-term growth initiative are our proactive investments in technology development and patent filings, which are intended to provide broad intellectual property coverage around emerging combination therapy approaches.” Further, the importance of these patent fillings lies in their pioneering role in defining and protecting the combined use of Excimer laser therapy with systemic pharmacologic agents, a significant advancement in the treatment of inflammatory and autoimmune skin diseases such as psoriasis, atopic dermatitis, leukoderma, alopecia areata, and vitiligo. Excimer lasers, particularly at 308 nm, allow for precise, high-dose, localized UVB exposure, delivering therapeutic light energy to affected skin areas while sparing healthy tissue. When used alone, they provide rapid lesion clearance, but their effects may be short-lived in severe or systemic disease. These pending patents strategically address these limitations by combining phototherapy with systemic treatments—including biologic drugs and JAK inhibitors—to deliver a synergistic therapeutic effect, ranging from enhanced treatment response including prolonged remission, potential reduction of the dosage for these drugs, as well as improved safety by limiting the UV exposure to only the affected skin area. XTRAC ® Excimer Laser Insurance Coverage As previously announced, the American Medical Association’s CPT Editorial Panel, in a landmark decision, approved updates to codes 96920–96922, expanding reimbursement eligibility for XTRAC ® Excimer Laser treatments to include all inflammatory and autoimmune skin conditions—such as vitiligo, atopic dermatitis, and alopecia areata—in addition to psoriasis, effective January 1, 2027. Based on STRATA’s 2025 insurance reimbursement coverage data, more than 75% of XTRAC ® excimer laser patients treated for non-psoriasis indications are currently covered by insurance. Upcoming code expansion will result in effectively tripling the addressable patient population while improving treatment economics for both providers and the Company. PUBLICATION DETAILS Chang S, Zhang L, Liu B, et al. Efficacy of oral JAK inhibitors combined with 308-nm excimer laser in pediatric progressive vitiligo: A multicenter study. Journal of the American Academy of Dermatology. Published online March 19, 2026. doi:10.1016/j.jaad.2026.02.096 About STRATA Skin Sciences, Inc. STRATA Skin Sciences is a medical technology company dedicated to developing, commercializing, and marketing innovative products for the in-office treatment of various dermatologic conditions, such as psoriasis, vitiligo, and acne. Its products include the XTRAC ® excimer laser, VTRAC ® lamp systems, and the TheraClear ® X Acne Therapy System. STRATA is proud to offer these exciting technologies in the U.S. through its unique Partnership Program. STRATA’s popular partnership approach includes a fee per treatment cost structure versus an equipment purchase, installation and use of the device, on-site training for practice personnel, service and maintenance of the equipment, dedicated account and customer service associates, and co-op advertising support to help raise awareness and promote the program within the practice. Safe Harbor This press release includes “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such statements. STRATA Skin Sciences undertakes no obligation to publicly update or revise any forward-looking statements. Investor & Media Contact STRATA Skin Sciences, Inc. 5 Walnut Grove Drive, Suite 140, Horsham, PA 19044 (215) 619-3200 | ir@strataskinsciences.com | strataskinsciences.com

Clinical Result

13 May 2026

·ir.eledon.com

Eledon Pharmaceuticals Reports First Quarter 2026 Financial Results and Recent Business Highlights

100% insulin independence achieved in 10 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026 IRVINE, Calif. , May 13, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2026 operating and financial results and provided recent business highlights. “In the first quarter of 2026, we achieved significant milestones in our tegoprubart program, including important data updates in kidney and islet cell transplantation and FDA Orphan Drug designation for tegoprubart in liver transplantation,” said David-Alexandre C. Gros , M.D., Chief Executive Officer of Eledon. “Looking ahead, we expect multiple catalysts in 2026, including regulatory engagements supporting the advancement of tegoprubart into Phase 3 development in kidney transplantation and discussions regarding a potential path to market in islet cell transplantation. We also plan to initiate several new clinical trials, including an investigator sponsored study in liver transplantation, and share new kidney transplant data from our Phase 2 BESTOW long-term extension study, building on encouraging 24-month Phase 1b results that demonstrated a durable safety profile and improved graft function.” First Quarter 2026 Business Highlights In March 2026 , announced updated results from an ongoing investigator-led trial at the University of Chicago Medicine Transplant Institute evaluating tegoprubart in 12 adults with high-risk type 1 diabetes undergoing allogenic islet transplantation. All 10 patients who are more than four weeks post-transplant achieved 100% insulin independence. There were no signs of graft rejection or de novo donor-specific HLA antibodies and no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, the current standard of care. The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation. Presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium in January 2026 . Results showed there were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m2 at 12 months to 74.2 mL/min/1.73 m2 at 24 months. 2026 Anticipated Upcoming Milestones Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment. Report long-term data from Phase 1b and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation. Receive FDA regulatory guidance on the path to market for tegoprubart in islet cell transplantation and xenotransplantation. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant. Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction. First Quarter 2026 Financial Results Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026 , compared to $133.3 million as of December 31, 2025 . The company expects current cash, cash equivalents and short-term investments to fund operations into 2Q 2027. Research and development (R&D) expenses for the first quarter of 2026 were $17.2 million , including $1.1 million of non-cash stock-based compensation expense, compared to $13.5 million , including $1.0 million of non-cash stock-based compensation expense, for the comparable period in 2025. General and administrative (G&A) expenses for the first quarter of 2026 were $4.0 million , including $1.1 million of non-cash stock-based compensation expense, compared to $4.4 million , including $1.8 million of non-cash stock-based compensation expense, for the comparable period in 2025. Net loss for the first quarter of 2026 was $39.0 million , or $0.33 per basic common share, compared to a net loss of $6.5 million , or $0.08 per basic common share, for the comparable period in 2025. Net loss in the first quarter of 2026 included a non-cash loss of $19.0 million from changes in the fair value of warrant liabilities, while the 2025 net loss included a non-cash gain of $10.1 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $20.1 million for the three months ended March 31, 2026 , and $16.6 million for the three months ended March 31, 2025 . About Eledon Pharmaceuticals and tegoprubart Eledon Pharmaceuticals , Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com. Follow Eledon Pharmaceuticals on social media: LinkedIn; X Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Stephen Jasper Gilmartin Group (858) 525 2047stephen@gilmartinir.com Media Contact: Jenna Urban CG Life(212) 253 8881jurban@cglife.com Source: Eledon Pharmaceuticals, Inc.

Clinical ResultPhase 2Orphan DrugFinancial StatementImmunotherapy

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.

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Indication	Country/Location	Organization	Date
Vernal Keratoconjunctivitis	South Korea	Taejoon Pharm Co., Ltd.	11 Jul 2019
Lung Diseases, Interstitial	Japan	Astellas Pharma, Inc.	14 Jun 2013
Small intestine transplantation rejection	Japan	Astellas Pharma, Inc.	26 Jul 2011
Colitis, Ulcerative	Japan	Astellas Pharma, Inc.	07 Jul 2009
Mucositis	Japan	Senju Pharmaceutical Co., Ltd.	25 Jan 2008
Allograft Rejection	European Union	Astellas Pharma Europe BV	23 Apr 2007
Allograft Rejection	Iceland	Astellas Pharma Europe BV	23 Apr 2007
Allograft Rejection	Liechtenstein	Astellas Pharma Europe BV	23 Apr 2007
Allograft Rejection	Norway	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	European Union	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	Iceland	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	Liechtenstein	Astellas Pharma Europe BV	23 Apr 2007
Liver transplant rejection	Norway	Astellas Pharma Europe BV	23 Apr 2007
Lupus Nephritis	Japan	Astellas Pharma, Inc.	26 Jan 2007
Rejection of pancreas transplant	Japan	Astellas Pharma, Inc.	19 Jan 2005
Lung transplant rejection	Japan	Astellas Pharma, Inc.	31 Jan 2003
Cardiac transplant rejection	Japan	Astellas Pharma, Inc.	20 Jun 2001
Myasthenia Gravis	Japan	Astellas Pharma, Inc.	20 Sep 2000
Dermatitis, Atopic	Japan	Maruho Co., Ltd.	16 Jun 1999
Bone marrow transplant rejection	Japan	Astellas Pharma, Inc.	30 Apr 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Arterial Hypertension	Phase 3	-	VIVUS, Inc.	29 May 2026
Renal and pancreas transplant rejection	Phase 3	United States	Veloxis Pharmaceuticals A/S	27 Feb 2019
Kidney Failure, Chronic	Phase 3	United States	Northwestern University	05 Sep 2017
Tremor	Phase 3	United States	Veloxis Pharmaceuticals A/S	01 Dec 2011
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Dana-Farber Cancer Institute, Inc.	01 Jun 2009
Hodgkin's Lymphoma	Phase 3	United States	Dana-Farber Cancer Institute, Inc.	01 Jun 2009
Indolent B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Dana-Farber Cancer Institute, Inc.	01 Jun 2009
Indolent Non-Hodgkin Lymphoma	Phase 3	United States	Dana-Farber Cancer Institute, Inc.	01 Jun 2009
Mantle-Cell Lymphoma	Phase 3	United States	Dana-Farber Cancer Institute, Inc.	01 Jun 2009
Non-Hodgkin Lymphoma	Phase 3	United States	Dana-Farber Cancer Institute, Inc.	01 Jun 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05907746 (CTgov)	Phase 2	GATA2 Deficiency \| Immunologic Deficiency Syndromes	13	Total Body Irradiation+Fludarabine+Post-Transplant Cyclophosphamide+Tacrolimus+mycophenolate mofetil+Briquilimab (Arm A -Briquilimab, Fludarabine, 200 Centigray (cGy) Total Body Irradiation)	pnujsalbju = xruxybeszv fmztzgfegl (fzcpyycodl, hvesmbftve - ymowvtwixb) View more	-	29 May 2026
				Total Body Irradiation+Fludarabine+Post-Transplant Cyclophosphamide+Tacrolimus+mycophenolate mofetil+Briquilimab (Arm B - Briquilimab, Fludarabine, Cyclophosphamide, 200 Centigray (cGy) Total Body Irradiation)	pnujsalbju = gtokhqcwas fmztzgfegl (fzcpyycodl, pyavpxjvsl - fagslrmora) View more
NCT04838288 (OPERATOR, CTgov)	Phase 4	-	56	Tacrolimus	zogmvqzjvt(nbaphtbarw) = gpdmpaixqc gvhlecogse (xadkwbdiuh, parufdbffe - jiaicynogm) View more	-	29 Apr 2026
NCT05077254 (CPAT-ISR, CTgov)	Phase 2	COVID-19 \| Renal transplant rejection \| Liver transplant rejection	48	COVID-19 Vaccine (Additional mRNA COVID-19 Vaccine Without ISR)	sdiqfwihkg(thyvobxenl) = dhqpwzjbru nhlfxpawcy (oazmpihvyg, jhnykctcee - yykzcpmqzg) View more	-	23 Apr 2026
				COVID-19 Vaccine (Additional mRNA COVID-19 Vaccine With ISR)	sdiqfwihkg(thyvobxenl) = ozxgrcmryi nhlfxpawcy (oazmpihvyg, vbcwbubzoz - poohsjdmcs) View more
NCT01384513 (CTgov)	Phase 2	Recurrent Adult Grade III Lymphomatoid Granulomatosis \| Refractory cytopenia with multilineage dysplasia and ringed sideroblasts \| Marginal zone lymphoma recurrent ... View more	40	Allogeneic hematopoietic stem cell transplantation+Fludarabine+Busulfan+Cyclophosphamide (CY)+Tacrolimus+mycophenolate mofetil	rdyhlgaotj = vxbcqpaptu wrczfnyuzu (seryeflffv, evdaaqjjsu - dpjaikuntk) View more	-	15 Apr 2026
NCT03856216 (CTgov)	Phase 2	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma \| Lymphoid neoplasm \| CD22 positive lymphoma ... View more	15	Bendamustine+Fludarabine+Rituximab (Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab))	tdycnnwuji = bhtmvqekgz ouzubqloii (swugxcfdhg, nvkvrmkneh - iixlqfvpuk) View more	-	15 Apr 2026
				Fludarabine+Melphalan (Cohort 2: FM (Fludarabine/Melphalan))	tdycnnwuji = yrnesrjtgt ouzubqloii (swugxcfdhg, lbkidrixyd - pvlqprcopc) View more
AAAAI2026	Not Applicable	Chronic Urticaria	33	Tacrolimus (Omalizumab-Refractory Chronic Spontaneous Urticaria)	uufyqsovib(hrpqyexnvy) = pznzflxlyd oosssvgkpu (rkjgdsznag ) View more	Positive	27 Feb 2026
ECCO2026	Not Applicable	Colitis, Ulcerative	30	Tacrolimus + Biologics	ffgndqsfdf(fmrxdeogtq) = Adverse events included renal dysfunction (n = 9), tremor (n = 5), headache (n = 1), nausea (n = 1), influenza A (n = 1), and cytomegalovirus antibody positivity (n = 3), but no severe adverse events were observed ibwxknlxsc (snkmvconhf )	Positive	18 Feb 2026
NCT01203722 (CTgov)	Phase 1/2	Acute Myeloid Leukemia \| Chronic Lymphocytic Leukemia \| Acute Lymphoblastic Leukemia ... View more	87	Allogeneic Blood or Marrow Transplant+Fludarabine+Cytoxan+Sirolimus+mycophenolate mofetil (REGIMEN B)	djxiacdqam = svpnrxdfje cmavbunjdt (ycyhtwmroq, fmmfboygzq - hevmdmgbob) View more	-	18 Feb 2026
				Allogeneic Blood or Marrow Transplant+Fludarabine+Cytoxan+Tacrolimus+mycophenolate mofetil (REGIMEN C)	djxiacdqam = ndteonfcio cmavbunjdt (ycyhtwmroq, sjdlroyulk - bpwajotzdj) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Graft vs Host Disease	121	Post-transplant cyclophosphamide with tacrolimus and mycophenolate (PTCy-Tac-MMF)	mmnzlcxdss(tofrjxdpbm) = iizkliywjt cawjrmmkan (uoaaxjaexa, 10.5 - 38.1) View more	Similar	04 Feb 2026
				Tacrolimus+Methotrexate	mmnzlcxdss(tofrjxdpbm) = ggikbdgwls cawjrmmkan (uoaaxjaexa, 4.1 - 17.3) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Hematopoietic stem cell transplantation	22	Intermittent IV bolus tacrolimus	pqtkprnkfq(ybcjdhxsgg) = bfopaxivwj esfviesolg (hdmkimepla ) View more	Positive	04 Feb 2026

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