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DRUG CLASS:

Immunosuppressant

1d
AGORAC: Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure (clinicaltrials.gov)
P3, N=332, Recruiting, Nantes University Hospital | Not yet recruiting --> Recruiting | Initiation date: Feb 2024 --> Dec 2024
Enrollment open • Trial initiation date
3d
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients (clinicaltrials.gov)
P2, N=60, Enrolling by invitation, Cedars-Sinai Medical Center | Trial primary completion date: Oct 2024 --> Oct 2025
Trial primary completion date
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sirolimus • methylprednisolone sodium succinate
3d
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis (clinicaltrials.gov)
P=N/A, N=50, Recruiting, The University of Hong Kong | Unknown status --> Recruiting | Trial completion date: Jun 2021 --> Dec 2028 | Trial primary completion date: Mar 2021 --> Dec 2028
Enrollment open • Trial completion date • Trial primary completion date
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CD4 (CD4 Molecule)
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cyclophosphamide
7d
Association between non-melanoma skin cancer, psoriasis, and immunomodulatory therapy: a national epidemiologic study. (PubMed, Arch Dermatol Res)
Of these drugs, IL-23 inhibitors (aOR 2.47 95% CI 1.17-5.18), Janus kinase inhibitors (aOR 2.32 95% CI 1.09-4.92), and azathioprine (aOR 2.16 95% CI 1.18-3.96) were the only classes that significantly contributed to increased NMSC risk in psoriasis patients.Psoriasis is independently associated with NMSC...NMSC is treatable and high-risk patients may benefit from increased surveillance or preventative counseling. Further prospective studies that assess medication dose and length of exposure should validate our findings.
Journal • Immunomodulating
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IL23A (Interleukin 23 Subunit Alpha)
9d
OPTIMIZE-2: Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery (clinicaltrials.gov)
P3, N=117, Terminated, Oculis | Trial completion date: Dec 2024 --> May 2024 | Recruiting --> Terminated; Sponsor decision to close study due to third-party administrative error preventing analysis of trial results. There was no issue in terms of quality of the investigational product, and no safety risk to any study subject.
Trial completion date • Trial termination • Surgery
13d
A case of gastric/duodenal diffuse large B cell lymphoma observed during the administration of tacrolimus/azathioprine for dermatomyositis. (PubMed, Clin J Gastroenterol)
Seven months later, the patient underwent follow-up EGD, and the disappearance of lymphoma cells was confirmed histopathologically by biopsy. Repeated and detailed endoscopic examination should be considered in an immunosuppressed patient with treatment-resistant gastric or duodenal ulcers.
Journal
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CD20 (Membrane Spanning 4-Domains A1)
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CD20 positive
16d
ATG Individualized Dosing Model in URD-PBSCT. (clinicaltrials.gov)
P2, N=30, Recruiting, Chinese PLA General Hospital | Initiation date: Dec 2019 --> Dec 2020 | Trial primary completion date: Aug 2024 --> Dec 2024
Trial initiation date • Trial primary completion date
20d
In vitro β-catenin attenuation by a mefloquine-loaded core-shell nano emulsion strategy to suppress liver cancer cells. (PubMed, Nanoscale Adv)
The core-shell nano-emulsion, incorporating a repurposed drug, could disrupt the β-catenin connections in the Wnt/β-catenin pathway. In conclusion, MQ/GNE-GNP could be a promising core-shell nano emulsion for the effective treatment of liver cancer by targeting the Wnt/β-catenin pathway.
Preclinical • Journal
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CTNNB1 (Catenin (cadherin-associated protein), beta 1)
20d
ONSET: 1 Vs 7 RATG Infusions in Renal Transplantation (clinicaltrials.gov)
P=N/A, N=75, Recruiting, Mario Negri Institute for Pharmacological Research | Not yet recruiting --> Recruiting
Enrollment open
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Simulect (basiliximab)
20d
Reduction of Maintenance Immunosuppression in Kidney Transplant Recipients during Acute Complicated Urinary Tract Infection (ACTRN12624001408572)
P4, N=112, Not yet recruiting, prof. Tomas Reischig, MD, PhD - Faculty of Medicine in Pilsen, Charles University, and Teaching Hospital
New P4 trial
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CRP (C-reactive protein)
20d
Haplo-HSCT for Myelofibrosis (clinicaltrials.gov)
P=N/A, N=39, Recruiting, Peking University People's Hospital | Not yet recruiting --> Recruiting | Initiation date: Jan 2025 --> Jan 2024
Enrollment open • Trial initiation date
22d
Mycophenolate Mofetil, an Inhibitor of Inosine Monophosphate Dehydrogenase, and Tofacitinib, a Janus Kinase Inhibitor, Attenuate Airway Inflammation and Hyperresponsiveness in a Mouse Model of Allergic Asthma. (PubMed, Molecules)
In turn, the results indicate that the anti-asthmatic action induced by the studied agents is not mediated by the generation of forkhead box protein 3-expressing CD4+ regulatory T cells. Clinical implication of the the results suggest that MMF and TFB may exert anti-asthmatic action, and thus they may be considered therapeutic options for the treatment of allergic asthma cases resistant to conventional/existing treatment.
Preclinical • Journal
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CD4 (CD4 Molecule) • IL33 (Interleukin 33) • ST2 (Suppression Of Tumorigenicity)
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CD4 expression
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tofacitinib
29d
Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma (clinicaltrials.gov)
P1, N=68, Recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Oct 2027 --> Feb 2028 | Trial primary completion date: Oct 2024 --> Feb 2025
Trial completion date • Trial primary completion date
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temozolomide
30d
Case report: Partial regression of metastatic squamous cell carcinoma with altered azathioprine dosage after long-term use in renal transplant patient. (PubMed, Front Immunol)
We hypothesize that this reaction was triggered by azathioprine dose reduction. Dose modification of long-term immunosuppressive medications in patients with a transplantation history who later develop SCCs warrants further investigation.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1)
30d
Mycophenolate mofetil after tacrolimus for refractory clinically amyopathic dermatomyositis: a case report. (PubMed, Front Pharmacol)
The patient showed a limited response to a combined therapy regimen of prednisone, iguratimod, and tacrolimus. This report also discusses the potential role of inflammatory cytokines in the pathophysiology of CADM and RP-ILD. Further research is required to confirm these results and investigate the application of MMF in maintenance therapy for CADM-associated RP-ILD.
Journal
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IFIH1 (Interferon Induced With Helicase C Domain 1)
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prednisone
1m
Switching from Conventional Immunosuppressants to Inebilizumab for the Treatment of Neuromyelitis Optica Spectrum Disorder (ChiCTR2400091194)
P4, N=80, Not yet recruiting, The Third Affiliated Hospital, Sun Yat-sen University; The Third Affiliated Hospital, Sun Yat-sen University
New P4 trial • Real-world evidence • Real-world
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Uplizna (inebilizumab-cdon)
1m
Addition of Inotuzumab Ozogamicin to Melphalan Plus Fludarabine Reduced-Intensity Conditioning Regimen of Allogeneic Transplantation in Patients with Acute Lymphoblastic Leukemia and Aggressive Lymphoid Malignancies: A Phase II Prospective Trial (ASH 2024)
We recently demonstrated that INO can be added safely to a non-myeloablative conditioning of bendamustine, fludarabine, and rituximab in patients with indolent lymphoid malignancies who required an allogeneic hematopoietic transplantation (HCT) (Am J Hematol 2024)...Patients who received transplants from MUDs received an additional dose of methotrexate 5 mg/m2 on day +11 and 1 mg/kg of rabbit anti-thymocyte globulin IV on days -1 and -2 before HCT...The patient who was in CR2 at transplant had Ph+ ALL and was maintained on ponatinib after HCT. Key prior therapies in ALL patients included blinatumomab (n=5) and INO (n=5)...The survival outcomes are encouraging and need to be validated in a larger number of patients. Currently, post-transplant cyclophosphamide has been implemented to lessen the risk of GVHD.
Clinical • P2 data
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TP53 (Tumor protein P53) • KMT2A (Lysine Methyltransferase 2A) • IKZF1 (IKAROS Family Zinc Finger 1) • CD22 (CD22 Molecule) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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TP53 mutation • CD22 expression • IKZF1 mutation • KMT2A mutation • MLL mutation
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clonoSEQ
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Rituxan (rituximab) • Iclusig (ponatinib) • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • Besponsa (inotuzumab ozogamicin) • bendamustine • melphalan • fludarabine IV
1m
Critical Crossroads: The Vital Role of Timely Diagnosis in Severe Amyopathic Dermatomyositis. (PubMed, Cureus)
Treatment with prednisolone and mycophenolate mofetil was initiated, resulting in subsequent clinical improvement. In conclusion, this case of anti-MDA5 positive CADM underscores the diverse range of clinical and radiological findings and the diagnostic challenges they pose. It highlights the importance of anti-MDA5 antibodies as a valuable diagnostic and prognostic tool, given their association with an elevated risk of developing interstitial lung disease (ILD), which may follow a rapidly progressive course and can be further complicated by pneumomediastinum.
Journal
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IFIH1 (Interferon Induced With Helicase C Domain 1)
2ms
Pivotal Study of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (DIAMOND-2) (clinicaltrials.gov)
P3, N=350, Recruiting, Oculis | Trial completion date: Dec 2025 --> Jun 2026 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2025 --> Jun 2026
Trial completion date • Trial initiation date • Trial primary completion date
2ms
NECESSITY: New Clinical End-points in Patients With Primary Sjögren's Syndrome (clinicaltrials.gov)
P2, N=300, Recruiting, Assistance Publique - Hôpitaux de Paris | Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Feb 2024 --> Apr 2025
Trial completion date • Trial primary completion date
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hydroxychloroquine • leflunomide
2ms
Trial completion
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cyclophosphamide • Campath (alemtuzumab) • fludarabine IV • busulfan
2ms
Romidepsin Maintenance After Allogeneic Stem Cell Transplantation (clinicaltrials.gov)
P1, N=23, Active, not recruiting, Ohio State University Comprehensive Cancer Center | Recruiting --> Active, not recruiting | N=10 --> 23 | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
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Istodax (romidepsin) • fludarabine IV • busulfan
2ms
SIMPLE: Envarsus XR Compared to Immediate Release Tacrolimus (clinicaltrials.gov)
P4, N=240, Active, not recruiting, Mayo Clinic | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Adherence
2ms
A case of rapidly progressive hair loss due to azathioprine, and the prevalence of NUDT15 variants among Japanese patients with autoimmune blistering diseases: A single-center retrospective observational study. (PubMed, J Dermatol)
Azathioprine is metabolized into thioguanine nucleotides (TGNs) which are its major active metabolites. Our findings indicate a prevalence of NUDT15 variants in AIBD patients that is similar to the prevalences of previous studies on patients with other diseases. These results emphasize the importance of screening for NUDT15 variants prior to initiating azathioprine treatment in Japanese patients with AIBDs.
Observational data • Retrospective data • Journal
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NUDT15 (Nudix Hydrolase 15)
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thioguanine
2ms
Induction of Remission in Autoimmune Hepatitis with Azathioprine Vs. MMF (clinicaltrials.gov)
P2/3, N=108, Not yet recruiting, Institute of Liver and Biliary Sciences, India
New P2/3 trial
2ms
Trial initiation date
2ms
New P2 trial • Post-transplantation
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cyclophosphamide
2ms
Evaluation of Anti-Inflammatory and Immunosuppressant Potential of Isotelekin in Lipopolysaccharide (LPS) Stimulated Macrophage (RAW 264.7) and Sheep Red Blood Cells (SRBC) Sensitized Murine Models. (PubMed, Adv Biol (Weinh))
Molecular studies, including western blot analysis and immunocytochemistry, revealed that Isotelekin reduced the expression of iNOS (Inducible nitric oxide synthase), COX-2 (Cyclo-Oxygenase 2), and p-IkBα (Phospho I-kappa-B-alpha), and significantly inhibited the nuclear translocation of NF-κB/p65. Based on these results, Isotelekin at 10 µm in in vitro and at 30 mg kg-1 in in vivo demonstrated strong anti-inflammatory and immunosuppressive therapeutic potential.
Preclinical • Journal
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10)
2ms
Enrollment closed • Enrollment change
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Rituxan (rituximab) • cyclophosphamide • Blincyto (blinatumomab) • sirolimus • melphalan • fludarabine IV • mesna • thiotepa • Neupogen (filgrastim)
2ms
Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov)
P1/2, N=24, Completed, National Institute of Allergy and Infectious Diseases (NIAID) | N=10 --> 24
Enrollment change
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everolimus • Actemra IV (tocilizumab) • methylprednisolone sodium succinate
2ms
Evaluation of 3 Different Doses of IV Busulfan (clinicaltrials.gov)
P2, N=177, Active, not recruiting, Institut Paoli-Calmettes | Unknown status --> Active, not recruiting | Trial completion date: Dec 2018 --> Jul 2026 | Trial primary completion date: Dec 2018 --> Jul 2026
Enrollment closed • Trial completion date • Trial primary completion date
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fludarabine IV • busulfan
2ms
HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis (clinicaltrials.gov)
P2, N=200, Recruiting, AHS Cancer Control Alberta | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
Trial completion date • Trial primary completion date
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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cyclosporine • methylprednisolone sodium succinate
3ms
TN28: STOP-T1D Low-Dose (ATG) (clinicaltrials.gov)
P2, N=101, Active, not recruiting, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting --> Active, not recruiting
Enrollment closed
3ms
Pregnancy outcomes in Greek women with inflammatory bowel disease: a longitudinal national retrospective study. (PubMed, Eur J Gastroenterol Hepatol)
The majority of Greek patients with IBD have a favorable pregnancy outcome. Active inflammation during gestation and a diagnosis of ulcerative colitis are negatively associated with pregnancy outcomes.
Retrospective data • Journal
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TNFA (Tumor Necrosis Factor-Alpha)
3ms
ATGAM General Investigation (clinicaltrials.gov)
P=N/A, N=5, Active, not recruiting, Pfizer | N=100 --> 5 | Trial completion date: Feb 2026 --> Jan 2027 | Trial primary completion date: Feb 2026 --> Jan 2027
Enrollment change • Trial completion date • Trial primary completion date
3ms
Trial withdrawal
3ms
Liver transplantation plus chemotherapy versus chemotherapy alone in patients with permanently unresectable colorectal liver metastases (TransMet): results from a multicentre, open-label, prospective, randomised controlled trial. (PubMed, Lancet)
In selected patients with permanently unresectable colorectal liver metastases, liver transplantation plus chemotherapy with organ allocation priority significantly improved survival versus chemotherapy alone. These results support the validation of liver transplantation as a new standard option for patients with permanently unresectable liver-only metastases.
Clinical • Journal
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BRAF (B-raf proto-oncogene)
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BRAF mutation
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everolimus • methylprednisolone sodium succinate
3ms
Personalization of thiopurine therapy: Current recommendations and future perspectives. (PubMed, Acta Pharm)
Despite great therapeutic advances in the field of biologics, small synthetic molecules such as thiopurines, including azathioprine, mercaptopurine, and thioguanine, remain an important therapeutic pillar in the treatment of inflammatory bowel disease, other autoimmune disorders, and cancer. In addition, the article takes a critical look at emerging research in the field of thiopurine pharmaco genomics featuring novel genetic markers and technological developments in genetic testing. Finally, the potential of integrated approaches that combine genetic, meta bolic, and clinical factors to further individualize thiopurine therapy is highlighted.
Review • Journal
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TPMT (Thiopurine S-Methyltransferase) • NUDT15 (Nudix Hydrolase 15)
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mercaptopurine • thioguanine
3ms
A Case of Autoimmune Myelofibrosis Associated With Autoimmune Hepatitis. (PubMed, J Hematol)
Prednisone was reinitiated at 1 mg/kg, and she was started on mycophenolate mofetil (MMF). Despite this, a rapid response to corticosteroids was observed including reversal of profound transfusion dependence, normalization of hemoglobin, and reversal of biochemical evidence of hepatic inflammation. A shared pathogenesis of autoimmune fibrosis in both the bone marrow and liver is speculative but suggested by the temporal association in this case.
Journal
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JAK2 (Janus kinase 2) • CALR (Calreticulin)
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prednisone
4ms
ANCA-associated vasculitis and lung cancer: an immunological perspective. (PubMed, Clin Exp Med)
In AAV patients, the use of cyclophosphamide and azathioprine (AZA) alone has a clear carcinogenic risk, with frequent use of CYC potentially posing a high risk for lung cancer. Although TNF inhibitors (TNFi) combined with CYC have carcinogenic risks, there is insufficient evidence to link them directly to an increased risk of lung cancer. For patients at high risk for lung cancer, the judicious use of immunosuppressants, timely computed tomography (CT), and lung cancer screening can reduce the risk of lung cancer in AAV patients.
Review • Journal
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IL6 (Interleukin 6) • IL10 (Interleukin 10)
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IL6 expression
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cyclophosphamide
4ms
Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
P4, N=204, Completed, Chinese PLA General Hospital | Recruiting --> Completed
Trial completion
4ms
Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA) (clinicaltrials.gov)
P3, N=84, Completed, University Medical Center Groningen | Unknown status --> Completed
Trial completion
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cyclophosphamide