[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$f1zpapc4p1mz5x":5},{"data":4},[],{"data":6,"error":10},{"id":7,"documentId":8,"slug":9,"name":9,"proprietary_name":10,"non_proprietary_name":10,"is_proprietary":10,"active_ingredient":10,"administration_route":10,"available_strength":10,"dosage_form":10,"dose_schedule":10,"drug_unit":10,"is_available_generically":10,"mechanism_of_action":10,"overdosage":10,"warning":10,"species":11,"citations":12,"dose_schedules":27,"available_strengths":48,"label_statements":62,"drug_classes":106,"specialties":112,"medical_conditions":113,"animal_species":119},1853,"blje9fnx5ihg8h16y7kk51x7","capromorelin",null,[],[13,19,23],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"EMA centrally authorised medicines","EMA reuse with attribution","https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fdocuments\u002Freport\u002Fmedicines-output-medicines-report_en.xlsx","load-reference-corpus.cjs","2026-09-07",{"source":20,"licence":21,"source_url":22,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients",{"source":24,"licence":25,"source_url":26,"harvested_by":17,"retrieved_at":18},"UK VMD PID","OGL v3.0","https:\u002F\u002Fwww.vmd.defra.gov.uk\u002Fproductinformationdatabase\u002Fdownloads\u002Fvmd_productinformationdatabase.xlsx",[28,35,40,45],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":33,"source_label":34},13670,"Administer 3 mg\u002Fkg once daily by mouth.","Dogs","Oral","The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches.","ENTYCE™",{"id":36,"dose_text":37,"species":38,"administration_route":32,"limitation":10,"source_label":39},13671,"2 mg\u002Fkg once daily","Cats","Elura™",{"id":41,"dose_text":42,"species":10,"administration_route":43,"limitation":10,"source_label":44},13672,"Administer ENTYCE orally at a dose of 3 mg\u002Fkg (1.4 mg\u002Flb) body weight once daily.\nTo administer ENTYCE follow the written instructions below and see illustrations 1 through 4 for administration steps.\n1.Gently shake the bottle.\n2.Remove the bottle cap and insert the provided dosing syringe firmly into the opening of the bottle.\n3.Turn the bottle upside down and withdraw the appropriate volume of solution. Return the bottle to the upright position before removing the syringe, and replace the cap.\n4.Administer the solution with the syringe into the dog's mouth.\nRinse the syringe and plunger with water between treatment doses. Leave the syringe and plunger apart to dry. Wash hands immediately after use.\nThe effectiveness of ENTYCE has not been evaluated beyond 4 days of treatment in the clinical field study (See Effectiveness).","ORAL","FDA application 141-457",{"id":46,"dose_text":47,"species":10,"administration_route":43,"limitation":10,"source_label":39},13673,"Administer ELURA orally at a dose of 2 mg\u002Fkg (0.9 mg\u002Flb) or 0.1 mL\u002Fkg (0.045 mL\u002Flb) body weight once daily.\nTo administer ELURA:\n•Remove the cap, insert the dosing syringe, invert the bottle, withdraw the appropriate amount of solution.\n•Return the bottle to the upright position, remove syringe, replace the cap.\n•Administer the solution into the cat's mouth.\n•Rinse the syringe and plunger with water and leave apart to dry.\nIf the cat is routinely fed meals, offer food 30 minutes after administering the dose.\nIf the cat vomits within 15 minutes or only receives a partial dose, then the dose may be re-administered.",[49,53,56,59],{"id":50,"strength_text":51,"dosage_form":52,"proprietary_name":34,"species":31,"source_label":34},11886,"Each milliliter of solution contains 30 milligrams (mg) capromorelin.","Oral Solution",{"id":54,"strength_text":55,"dosage_form":52,"proprietary_name":39,"species":38,"source_label":39},11887,"20 mg\u002FmL flavored oral solution",{"id":57,"strength_text":58,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":39},11888,"20 mg \u002F 1 mL",{"id":60,"strength_text":61,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":44},11889,"30 mg \u002F 1 mL",[63,67,70,73,75,79,83,86,89,93,96,99,103],{"id":64,"kind":65,"statement":66,"species":31,"limitation":33,"source_label":34},20049,"indication","For appetite stimulation in dogs.",{"id":68,"kind":65,"statement":69,"species":38,"limitation":10,"source_label":39},20050,"For management of weight loss in cats with chronic kidney disease.",{"id":71,"kind":65,"statement":72,"species":10,"limitation":10,"source_label":44},20051,"ENTYCE (capromorelin oral solution) is indicated for appetite stimulation in dogs.",{"id":74,"kind":65,"statement":69,"species":10,"limitation":10,"source_label":39},20052,{"id":76,"kind":77,"statement":78,"species":10,"limitation":10,"source_label":44},20053,"contraindication","ENTYCE should not be used in dogs that have a hypersensitivity to capromorelin.",{"id":80,"kind":81,"statement":82,"species":10,"limitation":10,"source_label":39},20054,"warning","User Safety Warnings\nNot for use in humans. Keep this drug, including used syringes, out of reach of children.\nWash hands immediately after use as this product may be dermally absorbed.\nConsult a physician in case of accidental ingestion by humans.\nTo obtain a Safety Data Sheet(s), contact Elanco US Inc. at 1-888-545-5973.\nFor oral use in cats only.\nAnimal Safety Warnings\nDo not use in cats with hypersomatotropism (acromegaly).\nELURA may increase serum glucose for several hours after dosing (see Animal Safety and Clinical Pharmacology). Use in cats with current or historical diabetes mellitus has not been evaluated and use may not be appropriate.\nKeep ELURA in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.",{"id":84,"kind":81,"statement":85,"species":10,"limitation":10,"source_label":44},20055,"User Safety Warnings:\nNot for use in humans. Keep this drug, including used syringes, out of reach of children. Wash hands immediately after use as this product may be dermally absorbed. Consult a physician in case of accidental ingestion by humans. To obtain a Safety Data Sheet(s), contact Elanco US Inc. at 1-888-545-5973.\nFor use in dogs only.\nAnimal Safety Warnings:\nKeep ENTYCE in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.",{"id":87,"kind":81,"statement":88,"species":10,"limitation":10,"source_label":39},20056,"Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans.\nFor oral use in cats only.\nDo not use in cats with hypersomatotropism (acromegaly).\nELURA may increase serum glucose for several hours after dosing (see Animal Safety and Clinical Pharmacology). Use in cats with current or historical diabetes mellitus has not been evaluated and use may not be appropriate.",{"id":90,"kind":91,"statement":92,"species":10,"limitation":10,"source_label":39},20057,"adverse_reaction","Safety was evaluated in a 56-day field effectiveness study in 176 client-owned cats (118 administered ELURA, 58 administered vehicle control) that received at least one dose.\nCats enrolled had ≥5% unintended weight loss and a history of chronic kidney disease (CKD). Cats had a mean age of 15 years and at enrollment 11.4% of the cats were in Stage 1 CKD, 66.5% were in Stage 2, 21.0% were in Stage 3, and 1.1% were in Stage 4.\nCats enrolled in the study had a variety of comorbid conditions: dental disease (88.1%), moderate or severe muscle loss (43.2%), heart murmur (28.4%), history of vomiting or underlying gastrointestinal disease (28.4%), hyperthyroidism (13.6%) and hypertension (9.7%).\nTable 1: Adverse Reactions in the Field Effectiveness Study\nNote: If an animal experienced the same event more than once, only the first occurrence was tabulated.\na Behavior change included hiding from the owner (8 ELURA, 1 vehicle control); owner reported difficulty administering medication (7 ELURA, 1 vehicle control); and redirected aggression to another household cat (2 ELURA, 1 vehicle control).\nb Two ELURA and 1 vehicle control cat increased by two CKD stages; 8 ELURA and 2 vehicle control cats increased one CKD stage. It could not be determined if the progressive renal disease was the natural course of the pre-existing disease or treatment related.\nAdverse Reaction\nELURA\n(n=118)\nVehicle Control\n(n=58)\nVomiting\n35 (29.6%)\n13 (22.4%)\nHypersalivation\n25 (21.2%)\n0 (0.0%)\nInappetence\n22 (18.6%)\n7 (12.0%)\nBehavior Change a\n17 (14.4%)\n3 (5.2%)\nLethargy\n16 (13.6%)\n6 (10.3%)\nAnemia\n11 (9.3%)\n1 (1.7%)\nDehydration\n11 (9.3%)\n2 (3.4%)\nStage of CKD Increased b\n10 (8.5%)\n3 (5.2%)\nDiarrhea\n9 (7.6%)\n2 (3.4%)\nUrinary Tract Infection\n8 (6.8%)\n2 (3.4%)\nHyperglycemia\n8 (6.8%)\n2 (3.4%)\nUpper Respiratory Infection\n7 (5.9%)\n1 (1.7%)\nHypercalcemia\n7 (5.9%)\n0 (0.0%)\nFacial Skin Lesion\n6 (5.1%)\n3 (5.2%)\nHyperkalemia\n5 (4.2%)\n0 (0.0%)\nAtaxia\n4 (3.4%)\n0 (0.0%)\nDiabetes Mellitus\n1 (0.8%)\n0 (0.0%)\nCongestive Heart Failure\n1 (0.8%)\n0 (0.0%)\nHypersalivation was generally associated with dosing and resolved within a few minutes.\nNine cats (8 ELURA and 1 vehicle control) either died or were euthanized during or shortly after the study. Six ELURA cats were euthanized or died from decompensated CKD. One ELURA cat was euthanized after study withdrawal on Day 33 for declining quality of life and recent identification of a new mass. One ELURA cat acutely declined and was euthanized for findings of nodules in both kidneys and diagnosis of sarcoma. The vehicle control cat was euthanized for acute onset of right hindlimb paresis and suspected embolic event. Two additional cats were diagnosed with neoplasia during the study (one ELURA cat with unspecified soft tissue sarcoma and one control cat with mammary adenocarcinoma) but completed the study.\nPost-Approval Experience (2025)\nThe following adverse events are based on post-approval adverse drug experience reporting for ELURA. Not all adverse events are reported to FDA\u002FCVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.\nThe following adverse events in cats are categorized in order of decreasing reporting frequency by body system and in decreasing order of reporting frequency within each body system:\nGastrointestinal: hypersalivation, vomiting\nGeneral: lethargy, anorexia, recumbency, weakness\nBehavioral: unusual behaviors, hiding, vocalization, hyperactivity\nCardiovascular: bradycardia, hypotension\nNeurological: loss of consciousness, sedation\nRespiratory: dyspnea",{"id":94,"kind":91,"statement":95,"species":10,"limitation":10,"source_label":39},20058,"Safety was evaluated in a 56-day field effectiveness study in 176 client-owned cats (118 administered ELURA, 58 administered vehicle control) that received at least one dose.\nCats enrolled had ≥5% unintended weight loss and a history of chronic kidney disease (CKD). Cats had a mean age of 15 years and at enrollment 11.4% of the cats were in Stage 1 CKD, 66.5% were in Stage 2, 21.0% were in Stage 3, and 1.1% were in Stage 4. Cats enrolled in the study had a variety of comorbid conditions: dental disease (88.1%), moderate or severe muscle loss (43.2%), heart murmur (28.4%), history of vomiting or underlying gastrointestinal disease (28.4%), hyperthyroidism (13.6%) and hypertension (9.7%).\nTable 1: Adverse Reactions in the Field Effectiveness Study\nNote: If an animal experienced the same event more than once, only the first occurrence was tabulated.\na Behavior change included hiding from the owner (8 ELURA, 1 vehicle control); owner reported difficulty administering medication (7 ELURA, 1 vehicle control); and redirected aggression to another household cat (2 ELURA, 1 vehicle control).\nb Two ELURA and 1 vehicle control cat increased by two CKD stages; 8 ELURA and 2 vehicle control cats increased one CKD stage. It could not be determined if the progressive renal disease was the natural course of the pre-existing disease or treatment related.\nAdverse Reaction\nELURA (n=118)\nVehicle Control (n=58)\nVomiting\n35 (29.6%)\n13 (22.4%)\nHypersalivation\n25 (21.2%)\n0 (0.0%)\nInappetence\n22 (18.6%)\n7 (12.0%)\nBehavior Change a\n17 (14.4%)\n3 (5.2%)\nLethargy\n16 (13.6%)\n6 (10.3%)\nAnemia\n11 (9.3%)\n1 (1.7%)\nDehydration\n11 (9.3%)\n2 (3.4%)\nStage of CKD Increased b\n10 (8.5%)\n3 (5.2%)\nDiarrhea\n9 (7.6%)\n2 (3.4%)\nUrinary Tract Infection\n8 (6.8%)\n2 (3.4%)\nHyperglycemia\n8 (6.8%)\n2 (3.4%)\nUpper Respiratory Infection\n7 (5.9%)\n1 (1.7%)\nHypercalcemia\n7 (5.9%)\n0 (0.0%)\nFacial Skin Lesion\n6 (5.1%)\n3 (5.2%)\nHyperkalemia\n5 (4.2%)\n0 (0.0%)\nAtaxia\n4 (3.4%)\n0 (0.0%)\nDiabetes Mellitus\n1 (0.8%)\n0 (0.0%)\nCongestive Heart Failure\n1 (0.8%)\n0 (0.0%)\nHypersalivation was generally associated with dosing and resolved within a few minutes.\nNine cats (8 ELURA and 1 vehicle control) either died or were euthanized during or shortly after the study. Six ELURA cats were euthanized or died from decompensated CKD. One ELURA cat was euthanized after study withdrawal on Day 33 for declining quality of life and recent identification of a new mass. One ELURA cat acutely declined and was euthanized for findings of nodules in both kidneys and diagnosis of sarcoma. The vehicle control cat was euthanized for acute onset of right hindlimb paresis and suspected embolic event. Two additional cats were diagnosed with neoplasia during the study (one ELURA cat with unspecified soft tissue sarcoma and one control cat with mammary adenocarcinoma) but completed the study. In voluntary post-approval reporting for extra-label use of a capromorelin product for dogs, the following adverse events have been reported in cats (listed in decreasing order of reporting frequency): bradycardia, lethargy, hypersalivation, hypotension, behavior change, and vomiting.\nTo report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US, Inc. at 1-888-545-5973.\nFor additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http:\u002F\u002Fwww.fda.gov\u002Freportanimalae.",{"id":97,"kind":91,"statement":98,"species":10,"limitation":10,"source_label":44},20059,"In a controlled field study, 244 dogs were evaluated for safety when administered either ENTYCE or a vehicle control (solution minus capromorelin) at a dose of 3 mg\u002Fkg once daily for 4 days. Enrolled dogs had a reduced or absent appetite for a minimum of 2 days prior to day 0 and had various medical conditions: arthritis (40); gastrointestinal disease (24); allergy (22); dental disease (22); cardiovascular disease (16); renal disease (13); and others. Some dogs may have experienced more than one of the adverse reactions during the study.\nThe following adverse reactions were observed:\nTable 1: Adverse Reactions reported in dogs administered ENTYCE oral solution compared to vehicle control\nAdverse Reactions\nENTYCE (n = 171)\nn (%)\nVehicle Control (n = 73)\nn (%)\nGASTROINTESTINAL\nDiarrhea\n12 (7.0 %)\n5 (6.8 %)\nVomiting\n11 (6.4 %)\n4 (5.5 %)\nHypersalivation\n4 (2.3 %)\n0 (0.0 %)\nAbdominal discomfort\n2 (1.2 %)\n0 (0.0 %)\nFlatulence\n2 (1.2 %)\n0 (0.0 %)\nNausea\n2 (1.2 %)\n0 (0.0 %)\nCLINICAL PATHOLOGY\nElevated blood urea nitrogen\n7 (4.1 %)\n2 (2.7 %)\nElevated phosphorus\n4 (2.3 %)\n1 (1.4 %)\nElevated creatinine\n1 (0.6 %)\n1 (1.4 %)\nOTHER\nPolydipsia\n7 (4.1 %)\n1 (1.4 %)\nLethargy\u002Fdepression\n2 (1.2 %)\n0 (0.0 %)\nThe following adverse reactions were reported in \u003C 1% of dogs administered ENTYCE: hyperactivity, increase fecal volume, increase gut sounds, and polyuria.\nPost-Approval Experience (2025):\nThe following adverse events are based on post-approval adverse drug experience reporting for ENTYCE. Not all adverse events are reported to FDA\u002FCVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.\nThe following adverse events in dogs are categorized in order of decreasing reporting frequency by body system and in decreasing order of reporting frequency within each body system:\nGastrointestinal: vomiting, hypersalivation, diarrhea\nGeneral: lethargy, polydipsia, weakness, hyperglycemia, recumbency\nBehavioral: Unusual behaviors (some of these behaviors were related to avoidance of medication), vocalization, hyperactivity\nNeurological: ataxia, loss of consciousness, disorientation, sedation\nRespiratory: panting, dyspnea\nCardiovascular: bradycardia, hypotension",{"id":100,"kind":101,"statement":102,"species":10,"limitation":10,"source_label":39},20060,"mechanism_of_action","Mechanism of Action\nELURA is a selective ghrelin receptor agonist. The ghrelin receptor is found in many tissues in various species and may have effects in the central nervous system, gastrointestinal tract, cardiovascular system and energy homeostasis. ELURA binds to receptors in the hypothalamus to stimulate appetite and in the pituitary to stimulate secretion of growth hormone (GH). Increased GH stimulates release of insulin like growth factor 1 (IGF-1) from the liver, which in turn can stimulate weight gain. IGF-1 remains elevated during administration of the drug.\nIn humans, IGF-1 elevation may act as a negative feedback regulator of GH, but this is unknown in cats. The clinical effects of ELURA in cats are thought to be due to a combination of increased food intake and metabolic changes resulting in weight gain.\nPharmacokinetics\nThe pharmacokinetic parameters of capromorelin were evaluated in a cross-over study in 4 male and 8 female laboratory cats receiving a single oral dose of ELURA at 2 mg\u002Fkg in the fed or fasted state. Following 8 hours of fasting, half the cats were fed a meal of canned food 30 minutes before dosing and the others continued to be fasted until 4 hours post ELURA administration. Blood samples were collected prior to dosing (pre-feeding) and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dosing for determination of serum capromorelin concentrations. Serum concentrations of capromorelin were measured using a liquid chromatography with mass spectrometry detection method. Blood samples were collected prior to dosing (pre-feeding) and at 8, 12, and 24 h post-dosing for determination of serum IGF-1.\nTable 2. Mean (Standard Deviation) Pharmacokinetic Parameters for Serum Capromorelin\nData were analyzed for only 10 and 6 cats in the fasted and fed groups respectively, because there was an insufficient number of quantifiable serum concentrations for analysis.\naMedian and Range\nbInsufficient data to calculate mean and standard deviation for T½\nTmax = time to maximum serum concentration\nCmax =maximum serum concentration\nAUClast = area under the curve from the time of dosing to the last quantifiable serum concentration\nT½= half-life\nCapromorelin was rapidly absorbed following oral administration of ELURA to fasted cats. The Cmax and AUClast for capromorelin were 55% and 43% lower, respectively, in the fed state, as compared to the fasted state. Serum IGF-1 values did not appear to be affected by the feeding state.\nParameter\nFasted\nFed\nTmax\na (hr)\n0.25 (0.25-1)\n(n=10)\n0.75 (0.5-4)\n(n=6)\nCmax (ng\u002FmL)\n59 ± 42\n(n=10)\n28 ± 20\n(n=6)\nAUClast (ng*hr\u002FmL)\n83 ± 42\n(n=10)\n51 ± 21\n(n=6)\nT½ (hr)\n1.12 ± 0.16\n(n=8)\nNAb",{"id":104,"kind":101,"statement":105,"species":10,"limitation":10,"source_label":44},20061,"Following oral administration of ENTYCE at a dose of 3 mg\u002Fkg to 12 Beagle dogs, absorption of capromorelin was rapid with the maximum concentration (Cmax) reached within 0.83 hr (Tmax). After Cmax, the plasma concentrations declined mono-exponentially with a short terminal half-life (T½) of approximately 1.19 hrs. There were no gender differences in capromorelin pharmacokinetics. The exposure (Cmax and AUC) of capromorelin increased with dose, but the increases were not dose proportional following single and repeat once daily administrations of capromorelin. There was no drug accumulation following repeat oral administration.\nTable 2. Plasma PK parameters following oral administration of 3 mg\u002Fkg of ENTYCE\nParameter\nMean\nSD\nTmax (hr)\n0.83\n0.58\nCmax (ng\u002FmL)\n330\n143\nAUCt (ng*hr\u002FmL)\n655\n276\nAUCinf (ng*hr\u002FmL)\n695\n262\nT½ (hr)\n1.19\n0.17\nThe mean absolute oral bioavailability of capromorelin was 44%. The mean total plasma clearance and volume of distribution was 18.9 mL\u002Fmin\u002Fkg and 2.0 L\u002Fkg, respectively. Capromorelin was not highly bound (unbound fraction 51%) to plasma protein. The protein binding was concentration-independent over the range of 10 to 1000 ng\u002FmL. In vitro (human liver microsomes) and in vivo (rats) metabolism studies suggest that capromorelin is metabolized by hepatic enzymes, mainly CYP3A4 and CYP3A5. Therefore, drugs that inhibit CYP3A4 and CYP3A5 activity may affect capromorelin metabolism. Following oral administration of radio-labelled capromorelin to dogs, capromorelin was excreted in urine (37%) and in feces (62%) within 72 hours.",[107],{"id":108,"documentId":109,"slug":110,"name":111},969,"ac2z1n6gqkm24akln60nbbo3","anterior-pituitary-lobe-hormones-and-analogues","Anterior pituitary lobe hormones and analogues",[],[114],{"id":115,"documentId":116,"slug":117,"title":118},95,"jjdlvbfrxh850tibm4vz4t5w","chronic-kidney-disease","Chronic Kidney Disease",[]]