{"shortAnswer":"Apomorphine is FDA-approved for \"off\" spells in advanced Parkinson's disease, as Apokyn shots and the Onapgo pump. For that use the evidence grade is strong-human. It is not approved for erectile dysfunction in the US. Taken with ondansetron, it can drop blood pressure and cause fainting.","url":"https://peptideindex.ai/compound/apomorphine","status":"fda-approved","statusCheckedAt":"2026-10-26T13:43:54.351Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:43:54.377Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"53a4aed3-382c-4f0d-bdc7-e5805b294082","object":"compound","slug":"apomorphine","name":"Apomorphine","attrs":{"name":"Apomorphine","class":"non-peptide","access":[{"type":"approved-product","detail":"Approved by FDA as a prescription shot under the skin, used as needed for \"off\" spells in advanced Parkinson's disease.","indication":"Acute, intermittent treatment of \"off\" episodes in advanced Parkinson's disease.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264","brand_names":["Apokyn"],"manufacturer":"MDD US"},{"type":"approved-product","detail":"Approved by FDA in 2025 as a prescription infusion under the skin by pump, through the waking day.","indication":"Treatment of motor fluctuations in adults with advanced Parkinson's disease.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214056","brand_names":["Onapgo"],"manufacturer":"MDD US"},{"type":"lawful-compounding","detail":"Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"}],"dosing":"From the Apokyn and Onapgo labels. Apokyn is a shot under the skin, never into a vein, and its dose is written in mL to avoid mistakes. The first dose, 0.1 to 0.2 mL (1 to 2 mg), is given while a health care provider checks blood pressure. The dose is raised by effect and tolerance to at most 0.6 mL (6 mg), with doses at least 2 hours apart. People with mild or moderate kidney problems start Apokyn at 0.1 mL (1 mg). Onapgo runs by pump under the skin, starting at 1 mg an hour and going up to 6 mg an hour, for up to 16 hours a day. Its daily total, extra doses included, is at most 98 mg. Onapgo cannot be swapped for apomorphine used as needed. Both labels advise trimethobenzamide for nausea, starting 3 days before the first dose. The prescriber sets the dose.","trials":[{"nct":"NCT07257861","url":"https://clinicaltrials.gov/study/NCT07257861","phase":"Not stated","title":"Interest of Continuous Subcutaneous Apomorphine in Parkinsonian Patients at the End of Life","status":"recruiting","sponsor":"Centre Hospitalier Régional d'Orléans","countries":["France"],"us_states":[]},{"nct":"NCT07422675","url":"https://clinicaltrials.gov/study/NCT07422675","phase":"Phase 1","title":"SAD Study in Patients With Parkinson's Disease and Motor Fluctuations","status":"recruiting","sponsor":"Serina Therapeutics","countries":["United States","Australia"],"us_states":["Colorado","Florida","Michigan"]},{"nct":"NCT07145190","url":"https://clinicaltrials.gov/study/NCT07145190","phase":"Not stated","title":"SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment","status":"recruiting","sponsor":"Bial - Portela C S.A.","countries":["Germany"],"us_states":[]},{"nct":"NCT07402928","url":"https://clinicaltrials.gov/study/NCT07402928","phase":"Not stated","title":"Optimistic and Pessimistic Dopamine Signals in the Human Brain: a Mapping and Modelling Study in Health and Parkinson's Disease","status":"recruiting","sponsor":"Danish Research Centre for Magnetic Resonance","countries":["Denmark"],"us_states":[]},{"nct":"NCT07219927","url":"https://clinicaltrials.gov/study/NCT07219927","phase":"Not stated","title":"Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:","status":"recruiting","sponsor":"Supernus Pharmaceuticals, Inc.","countries":["United States"],"us_states":["California","Florida","New York"]},{"nct":"NCT04957095","url":"https://clinicaltrials.gov/study/NCT04957095","phase":"Not applicable","title":"Motor Network Physiology","status":"recruiting","sponsor":"University of Texas Southwestern Medical Center","countries":["United States"],"us_states":["Texas"]},{"nct":"NCT05072015","url":"https://clinicaltrials.gov/study/NCT05072015","phase":"Not stated","title":"Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)","status":"not-yet-recruiting","sponsor":"University Hospital, Strasbourg, France","countries":["France"],"us_states":[]},{"nct":"NCT05213169","url":"https://clinicaltrials.gov/study/NCT05213169","phase":"Phase 2/Phase 3","title":"Apomorphine in Severe Brain-injured Patients","status":"recruiting","sponsor":"University of Liege","countries":["Belgium","Spain"],"us_states":[]},{"nct":"NCT03911726","url":"https://clinicaltrials.gov/study/NCT03911726","phase":"Not applicable","title":"Do Antipsychotic Agents Induce Supersensitivity in Humans: A Combined PET/MRI Study in Patients With Schizophrenia","status":"recruiting","sponsor":"Central Institute of Mental Health, Mannheim","countries":["Germany"],"us_states":[]}],"aliases":["Apokyn","Onapgo","Kynmobi","apomorphine hydrochloride"],"summary":"A prescription drug for \"off\" spells in advanced Parkinson's disease, approved as Apokyn shots and the Onapgo pump.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf","tier":"primary","type":"label","title":"Apokyn (apomorphine) injection label, revised January 2025"},{"n":2,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214056s005.pdf","tier":"primary","type":"label","title":"Onapgo (apomorphine) infusion label, revised May 2026"},{"n":3,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s007lbl.pdf","tier":"primary","type":"label","title":"Kynmobi (apomorphine) sublingual film label, revised May 2022"},{"n":4,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264","tier":"primary","type":"regulatory","title":"Drugs@FDA: Apokyn (apomorphine) injection, application 021264"},{"n":5,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214056","tier":"primary","type":"regulatory","title":"Drugs@FDA: Onapgo (apomorphine) infusion, application 214056"},{"n":6,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210875","tier":"primary","type":"regulatory","title":"Drugs@FDA: Kynmobi (apomorphine) sublingual film, application 210875"},{"n":7,"url":"https://www.federalregister.gov/documents/2025/01/15/2025-00743/teva-branded-pharmaceutical-products-randd-inc-et-al-withdrawal-of-approval-of-12-new-drug","tier":"primary","type":"regulatory","title":"Federal Register: withdrawal of approval of 12 new drug applications, Kynmobi among them, 2025"},{"n":8,"url":"https://www.federalregister.gov/documents/2000/03/02/00-4947/urology-subcommittee-of-the-advisory-committee-for-reproductive-health-drugs-notice-of-meeting","tier":"primary","type":"regulatory","title":"Federal Register: advisory subcommittee meeting on an apomorphine tablet for erectile dysfunction, 2000"},{"n":9,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":10,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list"},{"n":11,"url":"https://www.ecfr.gov/current/title-21/section-1308.12","tier":"primary","type":"regulatory","title":"21 CFR 1308.12: Schedule II, opiates excluding apomorphine"},{"n":12,"url":"https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs","tier":"primary","type":"regulatory","title":"FDA: understanding the risks of compounded drugs"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/11559309/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: apomorphine shots for \"off\" episodes in Parkinson's disease, 2001"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/31818699/","tier":"peer-reviewed","type":"rct","title":"Randomized phase 3 trial: apomorphine sublingual film for \"off\" episodes, 2020"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/30055903/","tier":"peer-reviewed","type":"rct","title":"Randomized trial (TOLEDO): apomorphine infusion in Parkinson's disease, 2018"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/35899977/","tier":"peer-reviewed","type":"human-trial","title":"Randomized thorough QT study of apomorphine sublingual film in Parkinson's disease, 2022"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/32964351/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review and meta-analysis: apomorphine for erectile dysfunction, 2020"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/18405767/","tier":"peer-reviewed","type":"rct","title":"Randomized crossover trial: sublingual apomorphine against sildenafil, 2008"},{"n":19,"url":"https://pubmed.ncbi.nlm.nih.gov/10379793/","tier":"peer-reviewed","type":"animal","title":"Rat study: apomorphine, dopamine signaling in the brain and erection, 1999"},{"n":20,"url":"https://clinicaltrials.gov/study/NCT07219927","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT07219927: patient experience with apomorphine infusion in the US"},{"n":21,"url":"https://www.pharmaceutical-technology.com/newsletters/supernus-wins-fda-approval-for-parkinsons-pump-on-fourth-try","tier":"established-news","type":"reference","title":"Pharmaceutical Technology: FDA approves an apomorphine infusion pump, February 2025"}],"known_risks":["Taken with ondansetron or other 5-HT3 drugs for nausea, blood pressure can drop sharply and people have passed out. The labels say never to combine them [^1] [^2].","Nausea and vomiting are common and can be severe. The labels advise a drug for nausea before the first dose [^1] [^2].","People have fallen asleep during daily activities with no warning. Many feel sleepy on it [^1] [^2].","Blood pressure can drop on standing, and people can faint or fall. Alcohol and blood pressure drugs make the drop larger [^1] [^2].","It can change the heart's rhythm, measured as the QT interval. The labels warn this can lead to a deadly rhythm or sudden death [^1] [^2].","In the Apokyn studies, 4% of people had chest pain, a heart attack, cardiac arrest or sudden death [^1].","Given into a vein by mistake, it has caused blood clots that traveled to the lungs. It is only for use under the skin [^1] [^2].","It may cause hallucinations. Some people get strong urges to gamble, spend or have sex that they cannot control [^1] [^2].","It may cause hemolytic anemia, where red blood cells break down. Some people needed a hospital stay [^1] [^3].","It can cause jerky moves a person cannot stop, called dyskinesia. It can also make them worse [^1] [^2].","Some men have had painful erections that last too long, called priapism [^1].","The Onapgo pump can cause lumps, redness and infection where the needle goes in [^2].","The Kynmobi film often caused mouth and throat sores or swelling [^3] [^14].","Its sulfite can cause allergic reactions, which can be life-threatening in some people [^1].","Based on animal studies, it may harm an unborn baby [^1] [^2]."],"short_answer":"Apomorphine is FDA-approved for \"off\" spells in advanced Parkinson's disease, as Apokyn shots and the Onapgo pump. For that use the evidence grade is strong-human. It is not approved for erectile dysfunction in the US. Taken with ondansetron, it can drop blood pressure and cause fainting.","evidence_grade":"strong-human","open_questions":["It is not known if it is a good choice for erectile dysfunction. A 2020 review said more trials are needed on its effects and harms [^17].","A 2022 study of 40 people found the film did not change the QT interval much. The labels still warn about it, so the size of the risk is not settled [^16] [^1].","In long rat studies, it damaged the retina of the eye. The label says no one knows if this matters for people [^1].","The 2018 pump trial compared it with salt water for only 12 weeks. Its 52-week phase was open-label, and that paper reports only the first 12 weeks [^15].","Nobody knows yet how the Onapgo pump does in daily US life. A US study of people using it at home is still running [^20]."],"section_routes":"The legal way to get apomorphine is a prescription [^1] [^2]. Apokyn shots and the Onapgo pump are approved for advanced Parkinson's disease [^4] [^5]. The Kynmobi film is no longer approved [^7].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^9]. A compounded drug is not FDA-approved, so FDA does not review its quality before sale [^12].\n\nA US study is following people who use the Onapgo pump at home [^20]. The trials block on this page lists open trials with their dates.","regulatory_as_of":"2026-10-26","section_evidence":"The evidence grade is strong-human for \"off\" spells in Parkinson's disease [^1] [^13] [^14] [^15]. In a 2001 trial, 29 people with advanced Parkinson's disease got apomorphine shots or dummy shots [^13]. At home, 95% of apomorphine shots ended an \"off\" spell, against 23% of dummy shots [^13].\n\nIn a 2018 trial in Europe, 107 people got an apomorphine pump or salt water for 12 weeks [^15]. Daily \"off\" time fell by about 2.5 hours on apomorphine and about half an hour on salt water [^15]. In a 2020 trial, 109 people used the film under the tongue or a dummy film [^14]. Movement scores got better on the film, but nearly a third stopped it, mostly for mouth and throat problems [^14].\n\nFor erectile dysfunction, a 2020 review of nine trials found it beat a dummy pill in most of them [^17]. After prostate surgery, the review found no clear gain [^17]. In a 2008 trial, sildenafil helped men more than apomorphine did [^18]. In a 1999 study in rats, apomorphine acting on the brain caused erections [^19]. No US label covers this use [^1] [^2] [^3].","regulatory_status":"fda-approved","section_what_it_is":"Apomorphine is a drug that acts on the brain's dopamine receptors, like the brain chemical dopamine [^1]. It is not a peptide.\n\nIt treats \"off\" spells in advanced Parkinson's disease [^1] [^2]. An \"off\" spell is when a person's usual Parkinson's medicine stops helping and symptoms return [^15]. Apokyn is a shot under the skin, used when a spell starts [^1]. Onapgo is a pump that feeds it under the skin through the waking day [^2]. FDA first approved apomorphine as Apokyn in 2004 [^1] [^4]. The Onapgo pump was approved in February 2025 [^5] [^21].","section_is_it_legal":"Apomorphine is FDA-approved: Drugs@FDA lists Apokyn shots and the Onapgo pump as approved prescription drugs [^4] [^5]. The approval covers \"off\" spells and motor swings in advanced Parkinson's disease [^1] [^2]. It does not cover erectile dysfunction, and no US label lists that use [^1] [^2] [^3]. Checked 26 October 2026.\n\nA film that melts under the tongue, Kynmobi, was approved in 2020 [^6]. FDA withdrew that approval as of February 2025, because the film was no longer sold [^7].\n\nIn 2000, FDA set a meeting of an advisory panel to review an apomorphine tablet for erectile dysfunction [^8]. The meeting notice gives no vote and no outcome [^8].\n\nFederal drug rules list opium-based drugs in Schedule II, but they leave apomorphine out [^11]. Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^9]. Apomorphine is not on FDA's 503A category list 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Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}