{"id":"megestrol-acetate","rwe":[{"pmid":"41895116","year":"2026","title":"Nontargeted screening of carbonyl-containing hormonal residues in meat products for food safety by using intelligent high-resolution mass spectrometry-based workflow.","finding":"","journal":"Food chemistry","studyType":"Clinical Study"},{"pmid":"41815544","year":"2026","title":"Long-term control for > 9 years with megestrol acetate-letrozole: metastatic endometrioid carcinoma case report.","finding":"","journal":"Frontiers in oncology","studyType":"Clinical Study"},{"pmid":"41676269","year":"2026","title":"Metformin combined with progesterone improves efficacy and reduces adverse reactions in early endometrial cancer.","finding":"","journal":"American journal of translational research","studyType":"Clinical Study"},{"pmid":"41671730","year":"2026","title":"Preclinical evaluation of progesterone combined with EDP-M scheme in 2D and 3D models of adrenocortical carcinoma.","finding":"","journal":"Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie","studyType":"Clinical Study"},{"pmid":"41663276","year":"2026","title":"Body mass index but not percentage weight loss was associated with the race/ethnicity of patients with advanced lung cancer: a cross-sectional study.","finding":"","journal":"Annals of palliative medicine","studyType":"Clinical Study"}],"_fda":{"id":"35ced36e-d65c-4dca-e063-6294a90ae85c","set_id":"01119031-9943-4afb-8b45-cb71682f0482","openfda":{"unii":["TJ2M0FR8ES"],"route":["ORAL"],"rxcui":["860225"],"spl_id":["35ced36e-d65c-4dca-e063-6294a90ae85c"],"brand_name":["Megestrol Acetate"],"spl_set_id":["01119031-9943-4afb-8b45-cb71682f0482"],"package_ndc":["17856-0060-1","17856-0060-3","17856-0060-2","17856-0060-4"],"product_ndc":["17856-0060"],"generic_name":["MEGESTROL ACETATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["MEGESTROL ACETATE"],"manufacturer_name":["ATLANTIC BIOLOGICALS CORP."],"application_number":["ANDA075671"],"original_packager_product_ndc":["64380-160"]},"version":"3","warnings":["WARNINGS Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility ). There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility section.) The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealedthe frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol acetate therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic megestrol acetate therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection)."],"components":["Rx only"],"overdosage":["OVERDOSAGE No serious unexpected side effects have resulted from studies involving megestrol acetate oral suspension administered in dosages as high as 1200 mg/day. In post-marketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with megestrol acetate oral suspension. In case of overdose, appropriate supportive measures should be taken. Megestrol acetate has not been tested for dialyzability, however, due to its low solubility it is postulated that dialysis would not be an effective means of treating overdose"],"description":["DESCRIPTION Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52. The chemical formula is C 24 H 32 O 4 and the structural formula is represented as follows: Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2. Chemical formula"],"precautions":["PRECAUTIONS General: Therapy with megestrol acetate oral suspension for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease and renal or psychiatric diseases. Effects on HIV viral replication have not been determined. Use with caution in patients with a history of thromboembolic disease. Use in Diabetics: Exacerbation of pre-existing diabetes with increased insulin requirements has been reported in association with the use of megestrol acetate. Information for Patients: Patients using megestrol acetate should receive the following instructions: This medication is to be used as directed by the physician. Report any adverse reaction experiences while taking this medication. Use contraception while taking this medication if you are a woman capable of becoming pregnant. Notify your physician if you become pregnant while taking this medication. Drug Interactions: Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied. Megestrol acetate may interact with warfarin and increase International Normalized Ratio (INR). Closely monitor INR in patients taking megestrol acetate and warfarin. Animal Toxicology: Long-term treatment with megestrol acetate may increase the risk of respiratory infections. A trend toward increased frequency of respiratory infections, decreased lymphocyte counts, and increased neutrophil counts was observed in a two-year chronic toxicity/carcinogenicity study of megestrol acetate conducted in rats. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis - Data on carcinogenesis were obtained from studies conducted in dogs, monkeys and rats treated with megestrol acetate at doses 53.2, 26.6 and 1.3 times lower than the proposed dose (13.3 mg/kg/day) for humans. No males were used in the dog and monkey studies. In female beagles, megestrol acetate (0.01, 0.1 or 0.25 mg/kg/day) administered for up to 7 years induced both benign and malignant tumors of the breast. In female monkeys, no tumors were found following 10 years of treatment with 0.01, 0.1 or 0.5 mg/kg/day megestrol acetate. Pituitary tumors were observed in female rats treated with 3.9 or 10 mg/kg/day of megestrol acetate for 2 years. The relationship of these tumors in rats and dogs to humans is unknown but should be considered in assessing the risk-to-benefit ratio when prescribing megestrol acetate oral suspension and in surveillance of patients on therapy. (See WARNINGS .) Mutagenesis - No mutagenesis data are currently available. Impairment of Fertility - Perinatal/postnatal (segment III) toxicity studies were performed in rats at doses (0.05 to 12.5 mg/kg) less than that indicated for humans (13.3 mg/kg); in these low dose studies, the reproductive capability of male offspring of megestrol acetate-treated females was impaired. Similar results were obtained in dogs. Pregnant rats treated with megestrol acetate showed a reduction in fetal weight and number of live births, and feminization of male fetuses. No toxicity data are currently available on male reproduction (spermatogenesis). Pregnancy: No adequate animal teratology information is available at clinically relevant doses. (See WARNINGS and PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility. ) Nursing Mothers: Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate oral suspension is required. Use in Women: Breakthrough bleeding was observed in all 10 female patients participating in the clinical trials. Megestrol acetate oral suspension is a progesterone derivative, which may induce vaginal bleeding in women. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Clinical studies of megestrol acetate oral suspension in the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease of other drug therapy. Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"how_supplied":["HOW SUPPLIED Megestrol acetate oral suspension, USP is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL. NDC 17856-0060-01 10ML NDC 17856-0060-02 20ML STORAGE: Store the oral suspension between 20° to 25°C (68° to 77°F). [See USP]. Dispense in a tight container. Protect from heat. SPECIAL HANDLING: Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or \"overdose\" at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS ). Women at risk of pregnancy should avoid such exposure. Distributed by: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179"],"effective_time":"20250523","clinical_studies":["DESCRIPTION OF CLINICAL STUDIES The clinical efficacy of megestrol acetate oral suspension was assessed in two clinical trials. One was a multicenter, randomized, double-blind, placebo-controlled study comparing megestrol acetate (MA) at doses of 100 mg, 400 mg, and 800 mg per day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 270 patients entered on study, 195 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12 week period or had one post baseline weight measurement but dropped out for therapeutic failure. The percent of patients gaining five or more pounds at maximum weight gain in 12 study weeks was statistically significantly greater for the 800 mg (64%) and 400 mg (57%) MA-treated groups than for the placebo group (24%). Mean weight increased from baseline to last evaluation in 12 study weeks in the 800 mg MA-treated group by 7.8 pounds, the 400 mg MA group by 4.2 pounds, the 100 mg MA group by 1.9 pounds and decreased in the placebo group by 1.6 pounds. Mean weight changes at 4, 8 and 12 weeks for patients evaluable for efficacy in the two clinical trials are shown graphically. Changes in body composition during the 12 study weeks as measured by bioelectrical impedance analysis showed increases innon-water body weight in the MA-treated groups (see CLINICAL STUDIES table). In addition, edema developed or worsened in only 3 patients. Greater percentages of MA-treated patients in the 800 mg group (89%), the 400 mg group (68%) and the 100 mg group (72%), than in the placebo group (50%), showed an improvement in appetite at last evaluation during the 12 study weeks. A statistically significant difference was observed between the 800 mg MA-treated group and the placebo group in the change in caloric intake from baseline to time of maximum weight change. Patients were asked to assess weight change, appetite, appearance, and overall perception of well-being in a 9 question survey. At maximum weight change only the 800 mg MA-treated group gave responses that were statistically significantly more favorable to all questions when compared to the placebo-treated group. A dose response was noted in the survey with positive responses correlating with higher dose for all questions. The second trial was a multicenter, randomized, double-blind, placebo-controlled study comparing megestrol acetate 800 mg/day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 100 patients entered on study, 65 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12 week period or had one post baseline weight measurement but dropped out for therapeutic failure. Patients in the 800 mg MA-treated group had a statistically significantly larger increase in mean maximum weight change than patients in the placebo group. From baseline to study week 12, mean weight increased by 11.2 pounds in the MA-treated group and decreased 2.1 pounds in the placebo group. Changes in body composition as measured by bioelectrical impedance analysis showed increases in non-water weight in the MA-treated group (see CLINICAL STUDIES table). No edema was reported in the MA-treated group. A greater percentage of MA-treated patients (67%) than placebo-treated patients (38%) showed an improvement in appetite at last evaluation during the 12 study weeks; this difference was statistically significant. There were no statistically significant differences between treatment groups in mean caloric change or in daily caloric intake at time to maximum weight change. In the same 9 question survey referenced in the first trial, patients' assessments of weight change, appetite, appearance, and overall perception of well-being showed increases in mean scores in MA-treated patients as compared to the placebo group. In both trials, no statistically significant differences were seen between the treatment groups with regard to laboratory abnormalities, , new opportunistic infections, lymphocyte counts, T 4 counts, T 8 counts, or skin reactivity tests ( see ADVERSE REACTIONS ). Megestrol Acetate Oral Suspension Clinical Efficacy Trials Trial 1 Study Accrual Dates 11/88 to 12/90 Trial 2 Study Accrual Dates 5/89 to 4/91 Megestrol Acetate, mg/day 0 100 400 800 0 800 Entered Patients 38 82 75 75 48 52 Evaluable Patients 28 61 53 53 29 36 Mean Change in Weight (lb) Baseline to 12 Weeks 0.0 2.9 9.3 10.7 -2.1 11.2 % Patients ≥ 5 Pound Gain at Last Evaluation in 12 Weeks 21 44 57 64 28 47 Mean Changes in Body Composition* Fat Body Mass (lb.) 0.0 2.2 2.9 5.5 1.5 5.7 Lean Body Mass (lb.) -1.7 -0.3 1.5 2.5 -1.6 -0.6 Water (liters) -1.3 -0.3 0.0 0.0 -0.1 -0.1 % Patients With Improved Appetite: At Time of Maximum Weight Change 50 72 72 93 48 69 At Last Evaluation in 12 Weeks 50 72 68 89 38 67 Mean Change in Daily Caloric Intake: Baseline to Time of Maximum Weight Change -107 326 308 646 30 464 *Based on bioelectrical impedance analysis determinations at last evaluation in 12 weeks. The following figures are the results of mean weight changes for patients evaluable for efficacy in trials 1 and 2 Trial 1 Trial 2"],"adverse_reactions":["ADVERSE REACTIONS Clinical Adverse Events: Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing megestrol acetate oral suspension. ADVERSE EVENTS% of Patients Reporting Trial 1 (N = 236) Trail 2 (N=87) Open Label Trial Megestrol Acetate mg/day No. of Patients Placebo 0 N=34 100 N=68 400 N=69 800 N=65 Placebo 0 N=38 800 N=49 1200 N=176 Diarrhea 15 13 8 15 8 6 10 Impotence 3 4 6 14 0 4 7 Rash 9 9 4 12 3 2 6 Flatulence 9 0 1 9 3 10 6 Hypertension 0 0 0 8 0 0 4 Asthenia 3 2 3 6 8 4 5 Insomnia 0 3 4 6 0 0 1 Nausea 9 4 0 5 3 4 5 Anemia 6 3 3 5 0 0 0 Fever 3 6 4 5 3 2 1 Libido Decreased 3 4 0 5 0 2 1 Dyspepsia 0 0 3 3 5 4 2 Hyperglycemia 3 0 6 3 0 0 3 Headache 6 10 1 3 3 0 3 Pain 6 0 0 2 5 6 4 Vomiting 9 3 0 2 3 6 4 Pneumonia 6 0 2 2 3 0 1 Urinary Frequency 0 0 1 2 5 2 1 Adverse events which occurred in 1 to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo. Body as a Whole - abdominal pain, chest pain, infection, moniliasis and sarcoma Cardiovascular System - cardiomyopathy and palpitation Digestive System - constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis Hemic and Lymphatic System - leukopenia Metabolic and Nutritional - LDH increased, edema and peripheral edema Nervous System - paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking Respiratory System - dyspnea, cough, pharyngitis and lung disorder Skin and Appendages - alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder Special Senses - amblyopia Urogenital System - albuminuria, urinary incontinence, urinary tract infection and gynecomastia Postmarketing - Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS ). To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The precise mechanism by which megestrol acetate produces effects in anorexia and cachexia is unknown at the present time. There are several analytical methods used to estimate megestrol acetate plasma concentrations, including gas chromatography-mass fragmentography (GC-MF), high pressure liquid chromatography (HPLC) and radioimmunoassay (RIA). The GC-MF and HPLC methods are specific for megestrol acetate and yield equivalent concentrations. The RIA method reacts to megestrol acetate metabolites and is, therefore, non-specific and indicates higher concentrations than the GC-MF and HPLC methods. Plasma concentrations are dependent, not only on the method used, but also on intestinal and hepatic inactivation of the drug, which may be affected by factors such as intestinal tract motility, intestinal bacteria, antibiotics administered, body weight, diet and liver function. The major route of drug elimination in humans is urine. When radiolabeled megestrol acetate was administered to humans in doses of 4 to 90 mg, the urinary excretion within 10 days ranged from 56.5 to 78.4% (mean 66.4%) and fecal excretion ranged from 7.7 to 30.3% (mean 19.8%). The total recovered radioactivity varied between 83.1 and 94.7% (mean 86.2%). Megestrol acetate metabolites which were identified in urine constituted 5 to 8% of the dose administered. Respiratory excretion as labeled carbon dioxide and fat storage may have accounted for at least part of the radioactivity not found in urine and feces. Plasma steady state pharmacokinetics of megestrol acetate were evaluated in 10 adult, cachectic male patients with acquired immunodeficiency syndrome (AIDS) and an involuntary weight loss greater than 10% of baseline. Patients received single oral doses of 800 mg/day of megestrol acetate oral suspension for 21 days. Plasma concentration data obtained on day 21 were evaluated for up to 48 hours past the last dose. Mean (±1SD) peak plasma concentration (C max ) of megestrol acetate was 753 (±539) ng/mL. Mean area under the concentration time-curve (AUC) was 10476 (±7788) ng x hr/mL. Median T max value was five hours. Seven of 10 patients gained weight in three weeks. Additionally, 24 adult, asymptomatic HIV seropositive male subjects were dosed once daily with 750 mg of megestrol acetate oral suspension. The treatment was administered for 14 days. Mean C max and AUC values were 490 (±238) ng/mL and 6779 (±3048) ng x hr/mL, respectively. The median T max value was three hours. The mean C min value was 202 (±101) ng/mL. The mean % of fluctuation value was 107 (±40). The effect of food on the bioavailability of megestrol acetate oral suspension has not been evaluated."],"indications_and_usage":["INDICATIONS AND USAGE Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS)."],"clinical_studies_table":["
Megestrol Acetate Oral Suspension Clinical Efficacy Trials
Trial 1 Study Accrual Dates 11/88 to 12/90Trial 2 Study Accrual Dates 5/89 to 4/91
Megestrol Acetate, mg/day01004008000800
Entered Patients388275754852
Evaluable Patients286153532936
Mean Change in Weight (lb)
Baseline to 12 Weeks0.02.99.310.7-2.111.2
% Patients ≥ 5 Pound Gain at Last Evaluation in 12 Weeks214457642847
Mean Changes in Body Composition*
Fat Body Mass (lb.)0.02.22.95.51.55.7
Lean Body Mass (lb.)-1.7-0.31.52.5-1.6-0.6
Water (liters)-1.3-0.30.00.0-0.1-0.1
% Patients With Improved Appetite:
At Time of Maximum Weight Change507272934869
At Last Evaluation in 12 Weeks507268893867
Mean Change in Daily Caloric Intake:
Baseline to Time of Maximum Weight Change-10732630864630464
*Based on bioelectrical impedance analysis determinations at last evaluation in 12 weeks.
"],"adverse_reactions_table":["
ADVERSE EVENTS% of Patients Reporting
Trial 1 (N = 236) Trail 2 (N=87) Open Label Trial
Megestrol Acetate mg/day No. of Patients Placebo 0 N=34 100 N=68 400 N=69 800 N=65 Placebo 0 N=38 800 N=49 1200 N=176
Diarrhea 15 13 8 15 8 6 10
Impotence 3 4 6 14 0 4 7
Rash 9 9 4 12 3 2 6
Flatulence 9 0 1 9 3 10 6
Hypertension 0 0 0 8 0 0 4
Asthenia 3 2 3 6 8 4 5
Insomnia 0 3 4 6 0 0 1
Nausea 9 4 0 5 3 4 5
Anemia 6 3 3 5 0 0 0
Fever 3 6 4 5 3 2 1
Libido Decreased 3 4 0 5 0 2 1
Dyspepsia 0 0 3 3 5 4 2
Hyperglycemia 3 0 6 3 0 0 3
Headache 6 10 1 3 3 0 3
Pain 6 0 0 2 5 6 4
Vomiting 9 3 0 2 3 6 4
Pneumonia 6 0 2 2 3 0 1
Urinary Frequency 0 0 1 2 5 2 1
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The recommended adult initial dosage of megestrol acetate oral suspension, USP is 800 mg/day (20 mL/day). Shake container well before using. In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective."],"spl_product_data_elements":["Megestrol Acetate Megestrol Acetate SODIUM BENZOATE SODIUM CITRATE SUCROSE CITRIC ACID MONOHYDRATE DOCUSATE SODIUM GLYCERIN XANTHAN GUM MEGESTROL ACETATE MEGESTROL milky white"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL image description image description"]},"tags":[{"label":"Progestin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"CYP2C9","category":"gene"},{"label":"ABCB1","category":"gene"},{"label":"G03AA04","category":"atc"},{"label":"Oral","category":"route"},{"label":"Suspension","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Anorexia from HIV","category":"indication"},{"label":"Cachexia due to HIV","category":"indication"},{"label":"Endometrial carcinoma","category":"indication"},{"label":"Hormone receptor positive malignant neoplasm of breast","category":"indication"},{"label":"Nutritional deficiency associated with AIDS","category":"indication"},{"label":"Bristol Myers Squibb","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Hormonal","category":"pharmacology"},{"label":"Appetite Stimulants","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Stimulants","category":"pharmacology"},{"label":"Contraceptive Agents","category":"pharmacology"},{"label":"Contraceptive Agents, Female","category":"pharmacology"},{"label":"Contraceptive Agents, Hormonal","category":"pharmacology"},{"label":"Contraceptives, Oral, Hormonal","category":"pharmacology"},{"label":"Contraceptives, Oral, Synthetic","category":"pharmacology"},{"label":"Reproductive Control Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":209.327,"date":"","count":377,"signal":"Death","source":"DrugCentral FAERS","actionTaken":"Reported 377 times (LLR=209)"},{"llr":169.685,"date":"","count":156,"signal":"Malignant neoplasm progression","source":"DrugCentral FAERS","actionTaken":"Reported 156 times (LLR=170)"},{"llr":163.326,"date":"","count":237,"signal":"Decreased appetite","source":"DrugCentral FAERS","actionTaken":"Reported 237 times (LLR=163)"},{"llr":118.523,"date":"","count":169,"signal":"Dehydration","source":"DrugCentral FAERS","actionTaken":"Reported 169 times (LLR=119)"},{"llr":107.405,"date":"","count":247,"signal":"Asthenia","source":"DrugCentral FAERS","actionTaken":"Reported 247 times (LLR=107)"},{"llr":100.959,"date":"","count":130,"signal":"Pulmonary embolism","source":"DrugCentral FAERS","actionTaken":"Reported 130 times (LLR=101)"},{"llr":99.364,"date":"","count":142,"signal":"Disease progression","source":"DrugCentral FAERS","actionTaken":"Reported 142 times (LLR=99)"},{"llr":94.787,"date":"","count":107,"signal":"Deep vein thrombosis","source":"DrugCentral FAERS","actionTaken":"Reported 107 times (LLR=95)"},{"llr":86.362,"date":"","count":25,"signal":"Respiratory tract infection bacterial","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=86)"},{"llr":85.813,"date":"","count":54,"signal":"Adrenal insufficiency","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=86)"},{"llr":84.096,"date":"","count":268,"signal":"Pneumonia","source":"DrugCentral FAERS","actionTaken":"Reported 268 times (LLR=84)"},{"llr":69.572,"date":"","count":26,"signal":"Respiratory tract infection viral","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=70)"},{"llr":67.03,"date":"","count":146,"signal":"Neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 146 times (LLR=67)"},{"llr":63.536,"date":"","count":302,"signal":"Diarrhoea","source":"DrugCentral FAERS","actionTaken":"Reported 302 times (LLR=64)"},{"llr":62.606,"date":"","count":183,"signal":"Anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 183 times (LLR=63)"}],"commonSideEffects":[{"effect":"Weight gain","drugRate":"frequent","severity":"unknown"},{"effect":"Thromboembolic phenomena","drugRate":"reported","severity":"unknown"},{"effect":"Heart failure","drugRate":"reported","severity":"unknown"},{"effect":"Nausea and vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Edema","drugRate":"reported","severity":"unknown"},{"effect":"Breakthrough menstrual bleeding","drugRate":"reported","severity":"unknown"},{"effect":"Dyspnea","drugRate":"reported","severity":"unknown"},{"effect":"Tumor flare","drugRate":"reported","severity":"unknown"},{"effect":"Hyperglycemia","drugRate":"reported","severity":"unknown"},{"effect":"Glucose intolerance","drugRate":"reported","severity":"unknown"},{"effect":"Alopecia","drugRate":"reported","severity":"unknown"},{"effect":"Hypertension","drugRate":"reported","severity":"unknown"},{"effect":"Carpal tunnel syndrome","drugRate":"reported","severity":"unknown"},{"effect":"Mood changes","drugRate":"reported","severity":"unknown"},{"effect":"Hot flashes","drugRate":"reported","severity":"unknown"},{"effect":"Malaise","drugRate":"reported","severity":"unknown"},{"effect":"Asthenia","drugRate":"reported","severity":"unknown"},{"effect":"Lethargy","drugRate":"reported","severity":"unknown"},{"effect":"Sweating","drugRate":"reported","severity":"unknown"},{"effect":"Rash","drugRate":"reported","severity":"unknown"}],"contraindications":["Adrenal cortical hypofunction","Chronic heart failure","Diabetes mellitus","Disease of liver","Hyperglycemia","Hypertensive disorder","Kidney disease","Male hypogonadism","Pregnancy, function","Thromboembolic disorder"],"specialPopulations":{"Lactation":"The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Megestrol acetate is present in human milk. There are no data on the effects of megestrol acetate on the breastfed infant or the effects on milk production. Because of the potential for HIV transmission and adverse effects on breastfed infant, instruct mothers not to breastfeed if they are taking megestrol a","Pregnancy":"No adequate animal teratology information is available at clinically relevant doses. (See WARNINGS and PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility.).","Geriatric use":"Clinical studies of megestrol acetate oral suspension in the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious,","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Bristol-Myers Squibb","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1703/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$62","description":"MEGESTROL 20 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MEGESTROL ACETATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:18:27.337868+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Megestrol Acetate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:18:34.459149+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:18:32.511866+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MEGESTROL ACETATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:18:32.804876+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:26.221318+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:26.221350+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Progesterone receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:34.459091+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201139/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:34.117938+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA075671","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:26.221360+00:00"}},"allNames":"megace","offLabel":[],"synonyms":["megestrol acetate","magestin","megestryl acetate","niagestin"],"timeline":[{"date":"1971-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BRISTOL MYERS SQUIBB to Bristol Myers Squibb"},{"date":"1971-08-18","type":"positive","source":"DrugCentral","milestone":"FDA approval (Bristol Myers Squibb)"},{"date":"1993-09-10","type":"positive","source":"FDA Orange Book","milestone":"Megace approved — 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1996-08-16","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 4 manufacturers approved"},{"date":"2005-07-05","type":"positive","source":"FDA Orange Book","milestone":"Megace Es approved — 125MG/ML"}],"aiSummary":"Megace (Megestrol Acetate) is a progestin medication developed by Bristol Myers Squibb, targeting the glucocorticoid receptor. It was approved by the FDA in 1971 for various indications, including anorexia from HIV, cachexia due to HIV, and hormone receptor-positive breast cancer. As an off-patent medication, Megace is available from multiple generic manufacturers. Key safety considerations include potential effects on blood sugar levels and liver function. Megace is a small molecule modality with high bioavailability of 90%.","approvals":[{"date":"1971-08-18","orphan":true,"company":"BRISTOL MYERS SQUIBB","regulator":"FDA"}],"brandName":"Megace","ecosystem":[{"indication":"Anorexia from HIV","otherDrugs":[{"name":"dronabinol","slug":"dronabinol","company":"Abbvie"}],"globalPrevalence":null},{"indication":"Cachexia due to HIV","otherDrugs":[],"globalPrevalence":null},{"indication":"Endometrial carcinoma","otherDrugs":[{"name":"medroxyprogesterone","slug":"medroxyprogesterone","company":"Pharmacia And Upjohn"},{"name":"progesterone","slug":"progesterone","company":"Alza"}],"globalPrevalence":420000},{"indication":"Hormone receptor positive malignant neoplasm of breast","otherDrugs":[{"name":"abemaciclib","slug":"abemaciclib","company":"Eli Lilly And Co"},{"name":"anastrozole","slug":"anastrozole","company":"Astrazeneca"},{"name":"everolimus","slug":"everolimus","company":"Novartis"},{"name":"exemestane","slug":"exemestane","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Nutritional deficiency associated with AIDS","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Glucocorticoid receptor","novelty":"Follow-on","targets":[{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"},{"gene":"CYP2C9","source":"DrugCentral","target":"Cytochrome P450 2C9","protein":"Cytochrome P450 2C9"},{"gene":"ABCB1","source":"DrugCentral","target":"Multidrug resistance protein 1","protein":"Multidrug resistance protein 1"},{"gene":"PGR","source":"DrugCentral","target":"Progesterone receptor","protein":"Progesterone receptor"}],"modality":"Small Molecule","drugClass":"Progestin","explanation":"","oneSentence":"","technicalDetail":"Megestrol Acetate acts as a selective glucocorticoid receptor agonist, binding to the glucocorticoid receptor and activating downstream signaling pathways that regulate appetite and metabolism."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Megestrol_acetate","title":"Megestrol acetate","extract":"Megestrol acetate (MGA), sold under the brand name Megace among others, is a progestin medication which is used mainly as an appetite stimulant to treat wasting syndromes such as cachexia. It is also used to treat breast cancer and endometrial cancer, and has been used in birth control. Megestrol acetate is generally formulated alone, although it has been combined with estrogens in birth control formulations. It is usually taken by mouth.","wiki_history":"==History==\nMegestrol acetate was synthesized at Syntex in 1959. It was derived from medroxyprogesterone acetate, which had been synthesized at Syntex in 1957. and this was followed by Serial 28 (1 mg MGA and 100 μg EE tablets) and Volidan 21 (4 mg MGA and 50 μg EE tablets) in 1964 and Nuvacon (2 mg MGA and 100 μg EE tablets) in 1967, all by British Drug Houses also in the United Kingdom. It was also marketed under the brand name Delpregnin (5 mg MGA and 100 μg mestranol tablets) by 1965, among others. Megestrol acetate-containing birth control pills were withdrawn after reports in the early 1970s of a high incidence of venous thromboembolism with the preparations.\n\nIn the early 1970s, megestrol acetate was found to be associated with mammary tumors in beagle dogs, and along with several other progestogens, was withdrawn as an oral contraceptive from several markets including the United Kingdom, Canada, and West Germany. It was also under investigation for use as a contraceptive in the United States, but development was discontinued in 1972 following the mammary toxicity findings in dogs, and megestrol acetate was never marketed as an oral contraceptive in the United States. Following its withdrawal from the market, megestrol acetate was eventually reintroduced for the treatment of hormone-sensitive cancers. In addition, megestrol acetate was marketed for veterinary use in dogs in 1969 in the United Kingdom and in 1974 in the United States.\n\nProgesterone was first found to be effective in the treatment of endometrial hyperplasia in 1951, Megestrol acetate was reported to be effective in the treatment of endometrial hyperplasia in the mid-1960s. Megestrol acetate was reportedly introduced for the treatment of endometrial cancer in the United States in 1971. Megestrol acetate was first studied in the treatment of breast cancer in 1967, and was one of the first progestins to be evaluated for the treatment of this disease. A secon","wiki_society_and_culture":"==Society and culture==\n\n===Generic names===\nMegestrol acetate is the generic name of the drug and its , , , and , while megestrol is the and and mégestrol the of megestrol, the free alcohol form of megestrol acetate. While the 19-nortestosterone progestins are consistently grouped into generations, the pregnane progestins that are or have been used in birth control pills are typically omitted from such classifications or are grouped simply as \"miscellaneous\" or \"pregnanes\". In any case, based on its date of introduction in such formulations of 1963, megestrol acetate could be considered a \"first-generation\" progestin."},"commercial":{"launchDate":"1971","_launchSource":"DrugCentral (FDA 1971-08-18, BRISTOL MYERS SQUIBB)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1667","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MEGESTROL%20ACETATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MEGESTROL ACETATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Megestrol_acetate","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:17:48.506600","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:18:37.294247+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ethinylestradiol","drugSlug":"ethinylestradiol","fdaApproval":"1943-06-25","relationship":"same-class"},{"drugName":"etynodiol","drugSlug":"etynodiol","fdaApproval":"1966-03-23","relationship":"same-class"},{"drugName":"norethisterone","drugSlug":"norethisterone","fdaApproval":"1962-05-21","relationship":"same-class"},{"drugName":"levonorgestrel","drugSlug":"levonorgestrel","fdaApproval":"1968-04-16","patentExpiry":"Sep 7, 2040","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"medroxyprogesterone","drugSlug":"medroxyprogesterone","fdaApproval":"1959-06-18","genericCount":16,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"desogestrel","drugSlug":"desogestrel","fdaApproval":"1992-12-10","relationship":"same-class"},{"drugName":"norgestimate","drugSlug":"norgestimate","fdaApproval":"1989-12-29","relationship":"same-class"},{"drugName":"drospirenone","drugSlug":"drospirenone","fdaApproval":"2019-05-23","patentExpiry":"Jun 28, 2031","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"megestrol acetate","indications":{"approved":[{"name":"Anorexia from HIV","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"HIV patients"},{"name":"Cachexia due to HIV","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"HIV patients"},{"name":"Endometrial carcinoma","source":"DrugCentral","snomedId":254878006,"regulator":"FDA","eligibility":"advanced carcinoma of the breast or endometrium","usPrevalence":null,"globalPrevalence":420000,"prevalenceMethod":"curated","prevalenceSource":"IARC GLOBOCAN, 2022"},{"name":"Hormone receptor positive malignant neoplasm of breast","source":"DrugCentral","snomedId":417181009,"regulator":"FDA","eligibility":"advanced carcinoma of the breast"},{"name":"Nutritional deficiency associated with AIDS","source":"DrugCentral","snomedId":420691000,"regulator":"FDA","eligibility":"AIDS patients"}],"offLabel":[{"name":"Malignant tumor of ovary","source":"DrugCentral","drugName":"MEGESTROL ACETATE","evidenceCount":82,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Bristol Myers Squibb","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"ethinylestradiol","brandName":"ethinylestradiol","genericName":"ethinylestradiol","approvalYear":"1943","relationship":"same-class"},{"drugId":"etynodiol","brandName":"etynodiol","genericName":"etynodiol","approvalYear":"1966","relationship":"same-class"},{"drugId":"norethisterone","brandName":"norethisterone","genericName":"norethisterone","approvalYear":"1962","relationship":"same-class"},{"drugId":"levonorgestrel","brandName":"levonorgestrel","genericName":"levonorgestrel","approvalYear":"1968","relationship":"same-class"},{"drugId":"medroxyprogesterone","brandName":"medroxyprogesterone","genericName":"medroxyprogesterone","approvalYear":"1959","relationship":"same-class"},{"drugId":"desogestrel","brandName":"desogestrel","genericName":"desogestrel","approvalYear":"1992","relationship":"same-class"},{"drugId":"norgestimate","brandName":"norgestimate","genericName":"norgestimate","approvalYear":"1989","relationship":"same-class"},{"drugId":"drospirenone","brandName":"drospirenone","genericName":"drospirenone","approvalYear":"2019","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05538897","phase":"PHASE1,PHASE2","title":"Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-03-31","conditions":["FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma","FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma","Metastatic Endometrial Endometrioid Adenocarcinoma","Recurrent Endometrial Endometrioid Adenocarcinoma"],"enrollment":96,"completionDate":"2027-01-31"},{"nctId":"NCT07462663","phase":"","title":"SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer","status":"NOT_YET_RECRUITING","sponsor":"Hospital Universitari de Bellvitge","startDate":"2026-05","conditions":["Endometrial Cancer","Endometrial Cancer Stage I","Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I","Atypical Endometrial Hyperplasia","Endometrial Intraepithelial Neoplasia","Obesity & Overweight","Obesity (BMI > 35)"],"enrollment":82,"completionDate":"2026-12"},{"nctId":"NCT07477808","phase":"PHASE3","title":"Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Hunan Province Tumor Hospital","startDate":"2026-04-01","conditions":["Non-small Cell Lung Cancer"],"enrollment":116,"completionDate":"2029-04-01"},{"nctId":"NCT00420563","phase":"PHASE2","title":"Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer","status":"COMPLETED","sponsor":"Centre Oscar Lambret","startDate":"2009-09-25","conditions":["Cancer"],"enrollment":88,"completionDate":"2011-01-19"},{"nctId":"NCT07319429","phase":"PHASE2,PHASE3","title":"Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification","status":"RECRUITING","sponsor":"Fudan University","startDate":"2026-01-25","conditions":["Endometrial Cancer","Fertility"],"enrollment":260,"completionDate":"2029-12-31"},{"nctId":"NCT06979596","phase":"PHASE2","title":"A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-08-11","conditions":["Malignant Neoplasm"],"enrollment":250,"completionDate":"2027-11-04"},{"nctId":"NCT04939090","phase":"PHASE3","title":"Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients","status":"RECRUITING","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2022-01-03","conditions":["Advanced Malignant Solid Neoplasm","Anorexia","Hematopoietic and Lymphoid Cell Neoplasm"],"enrollment":360,"completionDate":"2027-12-31"},{"nctId":"NCT07436793","phase":"PHASE2","title":"Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial","status":"NOT_YET_RECRUITING","sponsor":"New Mexico Cancer Research Alliance","startDate":"2026-03-01","conditions":["Endometrial Endometrioid Adenocarcinoma","Endometrial Hyperplasia"],"enrollment":140,"completionDate":"2031-06-30"},{"nctId":"NCT07408505","phase":"NA","title":"Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer","status":"RECRUITING","sponsor":"Shandong Cancer Hospital and Institute","startDate":"2026-01-20","conditions":["Advanced Pancreatic Ductal Adenocarcinoma","Cancer Anorexia-Cachexia Syndrome"],"enrollment":56,"completionDate":"2027-07-20"},{"nctId":"NCT07391826","phase":"PHASE2","title":"Megestrol Acetate Oral Suspension for Cachexia in Patients With cStage III Gastric/Gastroesophageal Junction Adenocarcinoma Receiving Neoadjuvant Therapy With Serplulimab Combined With SOX","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2026-02-15","conditions":["Stage III Gastric Cancer"],"enrollment":48,"completionDate":"2027-12-31"},{"nctId":"NCT06671548","phase":"PHASE3","title":"Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2024-01-15","conditions":["Heavy Menstrual Bleeding","Uterine Fibroids"],"enrollment":120,"completionDate":"2027-01-07"},{"nctId":"NCT07377734","phase":"PHASE2","title":"A Multicenter, Randomized, Open-Label, Controlled Clinical Trial of Intrauterine Injection of Recombinant Humanized Type III Collage in the Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia","status":"NOT_YET_RECRUITING","sponsor":"Wang Jianliu","startDate":"2026-01-30","conditions":["Atypical Endometrial Hyperplasia","Endometrial Cancer"],"enrollment":30,"completionDate":"2027-12-30"},{"nctId":"NCT07356037","phase":"PHASE3","title":"Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","startDate":"2026-01-10","conditions":["Cachexia","Hepatocellular Carcinoma"],"enrollment":68,"completionDate":"2027-12-31"},{"nctId":"NCT04576104","phase":"PHASE2","title":"Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Northwestern University","startDate":"2021-11-29","conditions":["Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia","Endometrial Carcinoma"],"enrollment":51,"completionDate":"2026-06-30"},{"nctId":"NCT07338487","phase":"PHASE1","title":"A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","status":"RECRUITING","sponsor":"Second Xiangya Hospital of Central South University","startDate":"2026-01-01","conditions":["Locally Advanced Cervical Cancer","Cachexia"],"enrollment":88,"completionDate":"2026-12-05"},{"nctId":"NCT03671811","phase":"PHASE2","title":"Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2019-01-21","conditions":["Atypical Endometrial Hyperplasia","Endometrial Carcinoma"],"enrollment":44,"completionDate":"2026-03-30"},{"nctId":"NCT06998758","phase":"PHASE3","title":"Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC","status":"RECRUITING","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","startDate":"2025-11-11","conditions":["Neoadjuvant Chemotherapy","Weight Loss"],"enrollment":60,"completionDate":"2028-12-31"},{"nctId":"NCT07254416","phase":"PHASE4","title":"A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients","status":"NOT_YET_RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2025-12-15","conditions":["Breast Cancer Patients Treated With T-DXd"],"enrollment":120,"completionDate":"2027-06-30"},{"nctId":"NCT07246070","phase":"PHASE2","title":"Nano-crystalline Megestrol Acetate for Chemotherapy-induced Nausea and Vomiting","status":"NOT_YET_RECRUITING","sponsor":"AIPING ZHOU","startDate":"2025-12","conditions":["Chemotherapy-Induced Nausea and Vomiting (CINV)"],"enrollment":127,"completionDate":"2026-12"},{"nctId":"NCT07243379","phase":"PHASE4","title":"A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia","status":"RECRUITING","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","startDate":"2025-09-25","conditions":["Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia","Multicenter Observational Study"],"enrollment":495,"completionDate":"2027-06-30"},{"nctId":"NCT03815019","phase":"PHASE4","title":"iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children","status":"COMPLETED","sponsor":"University of Kansas Medical Center","startDate":"2019-08-15","conditions":["Feeding Behavior","Feeding Disorder of Infancy or Early Childhood"],"enrollment":70,"completionDate":"2025-03-19"},{"nctId":"NCT07150663","phase":"PHASE3","title":"Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","startDate":"2025-08-20","conditions":["Non-small Cell Lung Cancer"],"enrollment":134,"completionDate":"2027-12-31"},{"nctId":"NCT07130617","phase":"PHASE1","title":"Evaluation of the Efficacy and Safety of Megestrol Acetate in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy","status":"NOT_YET_RECRUITING","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","startDate":"2025-09-29","conditions":["Efficacy","Safety","Megestrol Acetate","Adult Subject"],"enrollment":132,"completionDate":"2026-07-31"},{"nctId":"NCT07124195","phase":"PHASE3","title":"Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital of Xinxiang Medical College","startDate":"2025-08-10","conditions":["Malignant Solid Tumors","Moderate to High Emetogenic Chemotherapy (MEC/HEC) Drugs"],"enrollment":126,"completionDate":"2026-12-31"},{"nctId":"NCT05316467","phase":"PHASE2,PHASE3","title":"Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma","status":"RECRUITING","sponsor":"Xiaojun Chen","startDate":"2022-05-01","conditions":["Endometrial Carcinoma","Obese","Overweight","Fertility Issues"],"enrollment":89,"completionDate":"2027-02-28"},{"nctId":"NCT04491643","phase":"PHASE2","title":"Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma","status":"COMPLETED","sponsor":"Fudan University","startDate":"2020-09-01","conditions":["Endometrial Carcinoma Stage I"],"enrollment":48,"completionDate":"2025-04-11"},{"nctId":"NCT05316493","phase":"PHASE2,PHASE3","title":"Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia","status":"RECRUITING","sponsor":"Xiaojun Chen","startDate":"2022-06-13","conditions":["Atypical Endometrial Hyperplasia","Fertility Issues","Overweight and Obesity"],"enrollment":172,"completionDate":"2027-02-28"},{"nctId":"NCT07092137","phase":"PHASE2","title":"Nano-crystalline Megestrol Acetate for Anorexia-Cachexia Syndrome in Advanced Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Guangzhou Institute of Respiratory Disease","startDate":"2025-10-10","conditions":["Lung Cancer","Cachexia-Anorexia Syndrome"],"enrollment":116,"completionDate":"2027-10-10"},{"nctId":"NCT07077876","phase":"","title":"Surgical and Obstetric Outcomes in Endometrial 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