danazol oral / Generic mfg. - LARVOL DELTA

Refractory Tacrolimus Induced Autoimmune Hemolytic Anemia Requiring Sirolimus Conversion in a Liver Transplant Recipient (ACG 2026) - "Despite prednisone 120 mg daily, the patient remained transfusion-dependent, requiring daily to alternate-day pRBC transfusions with persistent hemoglobin < 7 g/dL and worsening hyperbilirubinemia. Weekly rituximab produced minimal response...Persistent hemolysis prompted escalation to IV methylprednisolone 200 mg daily. The clinical course was complicated by genital HSV infection requiring IV acyclovir...Danazol was added as adjunctive RBC maturation agent...In refractory cases, conversion from tacrolimus to sirolimus may restore immune balance through suppression of autoreactive B-cell and Th17 activity while maintaining graft function. This case highlights the importance of recognizing tacrolimus-associated warm AIHA and supports early consideration of sirolimus conversion in patients with refractory disease."

Clinical • Anemia • Autoimmune Hemolytic Anemia • Epstein-Barr Virus Infections • Fibrosis • Hematological Disorders • Hepatology • Herpes Simplex • Immunology • Infectious Disease • Inflammation • Metabolic Dysfunction-Associated Steatohepatitis • Respiratory Diseases • Transplant Rejection • Transplantation • HP

SURVIVAL IMPACT AND KINETICS OF HEMOGLOBIN IMPROVEMENT WITH MOMELOTINIB IN PATIENTS WITH MYELOFIBROSIS AND MODERATE TO SEVERE ANEMIA: POST HOC ANALYSES OF SIMPLIFY-1 AND MOMENTUM (EHA 2025) - "SIMPLIFY-1 and MOMENTUM were randomized, double-blind, phase 3 trials of momelotinib (n=215) vs ruxolitinib (n=217) in JAK inhibitor-naive patients and momelotinib (n=130) vs danazol (n=65) in JAK inhibitor-experienced patients, respectively. Anemia severity at BL dictates the probability and kinetics of achieving Hb >10 g/dL with momelotinib. Patients with BL moderate anemia were numerically more likely to achieve this threshold and faster than those with BL severe anemia, underscoring the benefits of earlier anemia intervention with momelotinib to maximize clinical outcomes. Regardless of anemia severity, patients who achieved Hb >10 g/dL by week 24 with momelotinib had numerically longer OS than those who did not, validating achievement of Hb levels above this threshold as a positive prognostic factor."

Clinical • Retrospective data • Anemia • Hematological Disorders • Myelofibrosis • ACVR1 • JAK1 • JAK2

MOMENTUM: Phase 3 randomized study of momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic myelofibrosis (MF) patients previously treated with a JAK inhibitor. (ASCO 2022) - P3 | "Prior JAKi was ruxolitinib in 195 pts (100%) and fedratinib in 9 pts (5%). In symptomatic and anemic MF pts, MMB was superior to DAN for symptom responses, transfusion requirements, and spleen responses with comparable safety and favorable survival. MMB may address a critical unmet need, particularly in MF pts with anemia."

Clinical • P3 data • Anemia • Hematological Disorders • Infectious Disease • Myelofibrosis • Pain • Thrombocytopenia • ACVR1 • JAK1 • JAK2

Association between hemoglobin (Hb) improvement and patient-reported outcomes (PROs) in patients (pts) with myelofibrosis (MF) and anemia: Post hoc pooled analysis of momelotinib (MMB) phase 3 trials. (ASCO 2024) - P3 | " The pooled treatment-agnostic analysis set included pts with anemia (baseline [BL] Hb <10 g/dL) from 3 phase 3 trials: S1 (JAK inhibitor [JAKi] naive; MMB vs ruxolitinib), S2 (JAKi experienced; MMB vs best available therapy), and MOMENTUM (JAKi experienced; MMB vs danazol). In these trial populations, Hb improvement at wk 24 was associated with improved HRQOL and symptoms in pts with MF and anemia. These results highlight the value of treatments with anemia-related benefits in improving the pt experience in MF."

P3 data • Patient reported outcomes • Retrospective data • Anemia • Hematological Disorders • Myelofibrosis

Longitudinal Safety of Luspatercept in the Treatment of Anemia in Patients with Myelofibrosis: Results from the ACE-536-MF-001 Study (ASH 2023) - P2 | "Methods Pts were enrolled into 4 cohorts based on transfusion dependence (TD) and stable ruxolitinib (RUX) treatment – cohort 1: NTD, no RUX; cohort 2: TD, no RUX; cohort 3A: NTD, RUX; cohort 3B: TD, RUX...Results In the safety population (N = 95; cohort 1, n = 22; cohort 2, n = 14; cohort 3A, n = 21; cohort 3B, n = 38), the most frequently used prior medications for anemia treatment were erythropoiesis-stimulating agents (23.2%, most frequently epoetin alfa [14.7%]), followed by danazol (11.6%), lenalidomide (2.1%), and thalidomide (1.1%)...In addition to benefits in anemia, the safety profile of LUSPA allowed most pts receiving RUX to maintain or increase their RUX dose, supporting maintenance of Janus kinase inhibitor therapy for adequate disease control of MF. Study support: Bristol Myers Squibb."

Clinical • Anemia • Beta-Thalassemia • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Inflammation • Ischemic stroke • Musculoskeletal Pain • Myelodysplastic Syndrome • Myelofibrosis • Oncology • Pain • Pneumonia • Renal Disease • Respiratory Diseases • Septic Shock

Momelotinib (MMB) Long-Term Safety: Pooled Data from Three Phase 3 Randomized-Controlled Trials (RCTs) (ASH 2022) - " Adult pts with high- and intermediate-risk MF were randomized to receive MMB or ruxolitinib (RUX; S1); MMB or best available therapy, which was RUX in 89% (S2) of patients; and MMB or danazol (MOMENTUM). We report the largest trial safety database to date for a JAK inhibitor in MF. MMB demonstrated a consistent safety profile without unexpected long-term or cumulative toxicity."

Clinical • P3 data • Acute Myelogenous Leukemia • Anemia • Genetic Disorders • Infectious Disease • Myelofibrosis • Neutropenia • Non-melanoma Skin Cancer • Pain • Skin Cancer • Solid Tumor • Thrombocytopenia • ACVR1 • JAK1 • JAK2

Momelotinib Long-Term Safety and Survival in Myelofibrosis: Integrated Analysis of Phase 3 Randomized-Controlled Trials. (PubMed, Blood Adv) - "Patients in the control arms (danazol in MOMENTUM; ruxolitinib in SIMPLIFY-1; best available therapy in SIMPLIFY-2) could cross over to receive momelotinib at the end of the 24-week randomized period, and all patients could continue momelotinib treatment after the completion of these studies via an extended access protocol. Incidence of AEs of clinical importance (eg, infections, malignant transformation, peripheral neuropathy, hemorrhage) did not increase over time. This analysis of one of the largest randomized trial databases for a JAK inhibitor to date in myelofibrosis demonstrated a consistent safety profile of momelotinib without long-term or cumulative toxicity."

Journal • P3 data • Infectious Disease • Myelofibrosis • Neutropenia • Pain • Thrombocytopenia • ACVR1 • JAK1 • JAK2

Outcomes of patients with myelofibrosis treated with ruxolitinib and anemia-supporting medications. (PubMed, Hematology) - "101 patients with baseline hemoglobin <12.0 g/dL initiated an erythropoiesis-stimulating agent (ESA) or danazol <3 months post-enrollment and maintained ESA/danazol ≥3 months; 97% initiated ESAs. This analysis suggests that patients treated with ruxolitinib and anemia-supporting care continued to receive optimal ruxolitinib dosing; spleen-length and symptom response rates in these patients were comparable to the overall JUMP population, the majority of whom did not have anemia. Results support use of anemia-supporting medications with ruxolitinib and may allow maintenance of ruxolitinib dose intensity in patients with myelofibrosis and anemia."

Clinical • Journal • Anemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

Progesterone receptor modulators for endometriosis. (PubMed, Cochrane Database Syst Rev) - "Mifepristone may improve dysmenorrhoea in women with endometriosis, but it might increase the prevalence of adverse events, such as hot flushes. The evidence is very uncertain regarding its effect on dyspareunia. Gestrinone may be less effective than leuprorelin in treating dysmenorrhoea, but it may improve dyspareunia. It may be associated with lower rates of hot flushes and similar rates of nausea. We are uncertain about the effect of gestrinone compared to danazol. We found insufficient evidence to permit firm conclusions about the safety and effectiveness of other progesterone receptor modulators."

Clinical • Journal • Review • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

MOMENTUM: PHASE 3 RANDOMIZED STUDY OF MOMELOTINIB (MMB) VERSUS DANAZOL (DAN) IN SYMPTOMATIC AND ANEMIC MYELOFIBROSIS (MF) PATIENTS PREVIOUSLY TREATED WITH A JAK INHIBITOR (EHA 2022) - P3 | "Prior JAKi was ruxolitinib in 195 pts (100%) and fedratinib in 9 pts (5%); mean duration of prior JAKi was 134 weeks. MMB may address a critical unmet need, particularly in MF pts with anemia. NCT04173494."

Clinical • P3 data • Anemia • Hematological Disorders • Infectious Disease • Myelofibrosis • Pain • Thrombocytopenia • ACVR1

Pacritinib Is a Potent ACVR1 Inhibitor with Significant Anemia Benefit in Patients with Myelofibrosis (ASH 2022) - "The subgroup of BAT that received erythroid support (erythropoiesis stimulating agents, danazol, thalidomide or analogs, or corticosteroids) was also analyzed...The inhibitory activity of pacritinib, momelotinib, fedratinib, and ruxolitinib against ACVR1 was assessed using a HotSpot assay (Reaction Biology Corporation)... Baseline characteristics of patients who were not TI (SIMPLIFY criteria) were similar between pacritinib (n=42) and BAT (n=44), including median hemoglobin (8.7 vs. 8.6 g/dL), median platelet count (43 vs. 41 x109/L), and percentage who received prior JAK2 inhibitor therapy (55% vs."

Clinical • Anemia • Hematological Disorders • Myelofibrosis • Thrombocytopenia • ACVR1 • IRAK1

CLINICAL OUTCOMES IN PATIENTS WITH MYELOFIBROSIS TREATED WITH RUXOLITINIB AND ANEMIA SUPPORTING MEDICATIONS (EHA 2025) - "For patients with anemia at myelofibrosis diagnosis who received ESA/danazol in combination with ruxolitinib, spleen and symptom responses were similar to those reported in the entire JUMP study population. In addition, most patients tolerated doses of ruxolitinib >25 mg daily and post-enrollment maintained an Hb level within 1.0 g/dL of baseline throughout the study period. These results reinforce the use of supportive care for anemia with an ESA/danazol combined with ruxolitinib and may allow for maintenance of ruxolitinib dose intensity in myelofibrosis patients with anemia."

Clinical • Clinical data • Anemia • Hematological Disorders • Myelofibrosis

Long-term survival adjusted for treatment crossover in patients (pts) with myelofibrosis (MF) treated with momelotinib (MMB) vs danazol (DAN) in the MOMENTUM trial. (ASCO 2024) - P2, P3 | "Consistent with the original unadjusted survival analysis, RPSFT models adjusting for the effects of treatment crossover showed prolonged OS and LFS in pts initially randomized to MMB vs those initially randomized to DAN; HRs in favor of MMB were lower after crossover adjustment. While these RPSFT analyses maintain the significance level of the original unadjusted analysis (P>.05), these results support the trend of long-term survival benefits with MMB vs DAN in JAKi–experienced pts with MF and anemia."

Clinical • Anemia • Hematological Disorders • Leukemia • Myelofibrosis • ACVR1 • JAK1 • JAK2

The Impact of Momelotinib on Patient Reported Quality of Life for Symptomatic and Anemic Patients with Myelofibrosis: Results from the Phase 3 Momentum Study (ASH 2022) - "MOMENTUM, a phase 3 study in symptomatic, anemic patients with MF who were previously treated with a JAKi, showed that MMB significantly improved disease-related symptoms compared to danazol (DAN) (24.6% vs 9.2%) as measured by achieving at least a 50% reduction in total symptom score (TSS50) at week 24 compared to baseline. Improvement in global quality of life as measured by EORTC QLQ-C30 was also greater in the MMB group with a proportion difference of 14.6% between MMB and DAN (95% CI: 1.5-27.7%; p = 0.04). Conclusions Consistent with the positive primary endpoint (TSS50) result of the MOMENTUM study, these responder, longitudinal, and time-to-event analyses demonstrate that MMB provides comprehensive improvements in disease-related symptoms with associated improvement in physical function and overall HRQoL compared with DAN in patients with MF."

Clinical • HEOR • P3 data • Anemia • Fatigue • Hematological Disorders • Immunology • Inflammation • Musculoskeletal Pain • Myelofibrosis • Oncology • Pain • Pruritus • ACVR1 • JAK2

Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study. (PubMed, Lancet Haematol) - P2, P3 | "Momelotinib was associated with durable symptom, spleen, and anaemia benefits, late responses after week 24, and favourable safety through week 48. These results highlight the potential benefits of treatment with momelotinib in patients with myelofibrosis, particularly those with anaemia."

Journal • P3 data • Anemia • Gastrointestinal Disorder • Infectious Disease • Myelofibrosis • Oncology • Pneumonia • Polycythemia Vera • Respiratory Diseases • Thrombocytopenia

Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study. (PubMed, Lancet) - P3 | "Treatment with momelotinib, compared with danazol, resulted in clinically significant improvements in myelofibrosis-associated symptoms, anaemia measures, and spleen response, with favourable safety. These findings support the future use of momelotinib as an effective treatment in patients with myelofibrosis, especially in those with anaemia."

Journal • P3 data • Acute Kidney Injury • Anemia • Infectious Disease • Myelofibrosis • Nephrology • Oncology • Pneumonia • Polycythemia Vera • Renal Disease • Respiratory Diseases • Thrombocytopenia • ACVR1 • JAK1 • JAK2

Updated Results from the Momentum Phase 3 Study of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor (ASH 2022) - P3 | "In these initial analyses of response duration, OL MMB maintained symptom, TI, and spleen responses with continued good survival and safety in the ITT (symptomatic and anemic MF pts) and in those with low PLT. MMB may address a critical unmet need, particularly in MF pts with anemia, including those with severe thrombocytopenia."

Clinical • P3 data • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelofibrosis • Neutropenia • Novel Coronavirus Disease • Oncology • Pain • Thrombocytopenia • ACVR1 • JAK1 • JAK2

Transfusion-related cost offsets and time burden in patients with myelofibrosis on momelotinib vs. danazol from MOMENTUM. (PubMed, Future Oncol) - " Reductions in transfusion associated with momelotinib are projected to result in cost and time savings compared with danazol in transfusion-dependent and transfusion-independent/requiring patients with myelofibrosis, respectively: annual medical costs ($53,143 and $46,455 per person), outpatient transfusion costs ($42,021 and $8,370 per person) and annual time savings (173 and 35 h per person). Fewer transfusions with momelotinib are projected to result in cost and time savings in patients with myelofibrosis and anemia compared with danazol."

Journal • Hematological Disorders • Myelofibrosis

Genetically supported targets and drug repurposing for sleep disorders: a Mendelian randomization systematic study. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Exploratory molecular docking yielded the most favorable predicted Vina score for the BCAN-danazol pair, and molecular dynamics simulation showed persistent local BCAN-danazol contacts despite substantial global conformational rearrangement of BCAN during the trajectory...Integrating genetic and multi-omic evidence identified candidate molecular targets and compound-gene associations relevant to sleep disorders. These findings provide hypotheses for subsequent functional and pharmacological validation."

Journal • CNS Disorders • Sleep Disorder

Telomerase Reverse Transcriptase (TERT) Mutation at a Price: Telomere Biology Disorder Presenting With Pancytopenia and Cirrhosis Requiring Liver Transplantation. (PubMed, Cureus) - "The patient had a clear hematologic response to danazol but developed progressive cirrhosis with portal hypertension, ultimately requiring orthotopic liver transplantation with sleeve gastrectomy; after transplant, liver chemistries normalized, but cytopenias recurred under tacrolimus-based immunosuppression. This case highlights the need to consider TBDs in adults with unexplained macrocytic cytopenias and progressive liver disease, and to recognize that liver transplantation corrects hepatic failure but not the underlying bone marrow disorder."

Journal • Cardiovascular • Fibrosis • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Hypertension • Immunology • Liver Cirrhosis • Liver Failure • Portal Hypertension • Transplantation • TERT

A Retrospective Analysis of Characteristics and Outcomes of Paroxysmal Nocturnal Hemoglobinuria Patients, not Having Access to Standard of Care. (PubMed, Indian J Hematol Blood Transfus) - "Patients received supportive care, including transfusions (66.67%), steroids (28.8%), calcineurin inhibitors (42.2%), and danazol (64.4%)...Supportive care, in the absence of C5 inhibitors, is associated with poor outcomes, highlighting the need for improved access to standard of care treatments. The online version contains supplementary material available at https://doi.org/10.1007/s12288-025-02263-w."

Journal • Retrospective data • Cardiovascular • Complement-mediated Rare Disorders • Hematological Disorders • Infectious Disease • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Thrombosis

Revisiting the role of danazol in the contemporary management of endometriosis-related pain: a systematic review. (PubMed, Expert Opin Pharmacother) - "International Prospective Register of Systematic Reviews (PROSPERO), CRD420251088044. Available at: https://www.crd.york.ac.uk/prospero."

Journal • Review • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Revisiting accessible therapies for the management of Myelodysplastic Syndromes: A retrospective analysis of danazole, nandrolone or both. (ASH 2025) - "More than half of the patients treated with androgen therapy achieved HI within a median of two months. These results support the potential role of androgens in select patients and reinforce their utility in resource-limited settings or in patient's ineligible for other disease-modifying therapies.The relatively low incidence of death without hematologic response may illustrate a subgroup of non-responding patients who could still benefit from extended androgen therapy or alternative treatments.The low incidence of disease progression and favorable survival outcomes underscore the potential benefit of androgen therapy in this population.Future prospective studies are needed to define predictive markers of response and to explore the role of combination androgen therapy in MDS."

Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome

Low-dose baricitinib plus danazol in primary immune thrombocytopenia: a randomized, controlled phase 2 trial. (PubMed, Nat Commun) - P2 | "7232188). ClinicalTrials.gov identifier: NCT05852847."

Clinical • Journal • P2 data • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Integrative drug repositioning identifies FDA-approved inhibitors of HSP90AA1 with therapeutic potential in colorectal cancer. (PubMed, Bioorg Chem) - "Docking and 200 ns molecular dynamics showed stable binding of all four in the HSP90α ATP-binding pocket, with hydrogen bonding and favorable MM/GBSA free energies (-30.59 kcal/mol for danazol to -37.37 kcal/mol for rifapentine; reference NVP-AUY922 -47.99 kcal/mol). In vitro, the drugs suppressed proliferation and induced apoptosis in HCT116, LoVo, and HCT-15 cells, with IC₅₀ values of 2.60-13.15 μM. These results identify unreported HSP90AA1 inhibitors in CRC and establish a generalizable repositioning framework."

FDA event • Journal • Colorectal Cancer • Oncology • Solid Tumor • CDC37 • HSP90AA1