# Apomorphine 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. Status checked: 2026-10-26. Last verified: 2026-10-26. Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264 This page has not been individually reviewed by a clinician. Information, not medical advice. | Fact | Value | Tier | Checked | Source | |---|---|---|---|---| | Also called | Apokyn, Onapgo, Kynmobi, apomorphine hydrochloride | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf) | | Class | non-peptide | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf) | | Regulatory status | fda-approved | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264) | | Status source read | 2026-10-26 | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264) | | Evidence grade | strong-human | our assessment | 2026-10-26 | [source](https://peptideindex.ai/methodology#evidence-grade) | | Label 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. | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf) | ## Name Apomorphine Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf ## Summary A prescription drug for "off" spells in advanced Parkinson's disease, approved as Apokyn shots and the Onapgo pump. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf ## 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. Source: https://peptideindex.ai/methodology#short-answer ## 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]. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf ## What nobody knows yet - 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]. Source: https://pubmed.ncbi.nlm.nih.gov/30055903/ ## 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. It 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]. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf ## Where it stands legally 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. A 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]. In 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]. Federal 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 [^10]. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264 ## What the evidence shows 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]. In 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]. For 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]. Source: https://pubmed.ncbi.nlm.nih.gov/11559309/ ## Legitimate ways to get it 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]. Pharmacies 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]. A 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. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf ## Access routes Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264 ### Approved product Detail: Approved by FDA as a prescription shot under the skin, used as needed for "off" spells in advanced Parkinson's disease. Brand names: Apokyn Manufacturer: MDD US Indication: Acute, intermittent treatment of "off" episodes in advanced Parkinson's disease. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264 ### Approved product Detail: Approved by FDA in 2025 as a prescription infusion under the skin by pump, through the waking day. Brand names: Onapgo Manufacturer: MDD US Indication: Treatment of motor fluctuations in adults with advanced Parkinson's disease. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214056 ### Lawful compounding Detail: Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug. Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ## Recruiting trials Snapshot date: 2026-10-26. A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record. - 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 none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed - 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 none listed Source: https://clinicaltrials.gov/api/v2/studies?query.intr=apomorphine&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState ## Sources Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf ### 1. Apokyn (apomorphine) injection label, revised January 2025 Type: label Tier: primary Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf ### 2. Onapgo (apomorphine) infusion label, revised May 2026 Type: label Tier: primary Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214056s005.pdf ### 3. Kynmobi (apomorphine) sublingual film label, revised May 2022 Type: label Tier: primary Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s007lbl.pdf ### 4. Drugs@FDA: Apokyn (apomorphine) injection, application 021264 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264 ### 5. Drugs@FDA: Onapgo (apomorphine) infusion, application 214056 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214056 ### 6. Drugs@FDA: Kynmobi (apomorphine) sublingual film, application 210875 Type: regulatory Tier: primary Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210875 ### 7. Federal Register: withdrawal of approval of 12 new drug applications, Kynmobi among them, 2025 Type: regulatory Tier: primary Source: 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 ### 8. Federal Register: advisory subcommittee meeting on an apomorphine tablet for erectile dysfunction, 2000 Type: regulatory Tier: primary Source: https://www.federalregister.gov/documents/2000/03/02/00-4947/urology-subcommittee-of-the-advisory-committee-for-reproductive-health-drugs-notice-of-meeting ### 9. FDA: bulk drug substances used in compounding under section 503A Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### 10. FDA: 503A bulk drug substances category list Type: regulatory Tier: primary Source: https://www.fda.gov/media/94155/download ### 11. 21 CFR 1308.12: Schedule II, opiates excluding apomorphine Type: regulatory Tier: primary Source: https://www.ecfr.gov/current/title-21/section-1308.12 ### 12. FDA: understanding the risks of compounded drugs Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs ### 13. Randomized trial: apomorphine shots for "off" episodes in Parkinson's disease, 2001 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/11559309/ ### 14. Randomized phase 3 trial: apomorphine sublingual film for "off" episodes, 2020 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/31818699/ ### 15. Randomized trial (TOLEDO): apomorphine infusion in Parkinson's disease, 2018 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/30055903/ ### 16. Randomized thorough QT study of apomorphine sublingual film in Parkinson's disease, 2022 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/35899977/ ### 17. Systematic review and meta-analysis: apomorphine for erectile dysfunction, 2020 Type: systematic-review Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/32964351/ ### 18. Randomized crossover trial: sublingual apomorphine against sildenafil, 2008 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/18405767/ ### 19. Rat study: apomorphine, dopamine signaling in the brain and erection, 1999 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/10379793/ ### 20. ClinicalTrials.gov NCT07219927: patient experience with apomorphine infusion in the US Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT07219927 ### 21. Pharmaceutical Technology: FDA approves an apomorphine infusion pump, February 2025 Type: reference Tier: established-news Source: https://www.pharmaceutical-technology.com/newsletters/supernus-wins-fda-approval-for-parkinsons-pump-on-fourth-try Last verified: 2026-10-26. Sources: - https://clinicaltrials.gov/api/v2/studies?query.intr=apomorphine&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState - https://peptideindex.ai/methodology#evidence-grade - https://peptideindex.ai/methodology#short-answer - https://pubmed.ncbi.nlm.nih.gov/11559309/ - https://pubmed.ncbi.nlm.nih.gov/30055903/ - https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf - https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264 [^1]: Apokyn (apomorphine) injection label, revised January 2025 https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf [^2]: Onapgo (apomorphine) infusion label, revised May 2026 https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214056s005.pdf [^3]: Kynmobi (apomorphine) sublingual film label, revised May 2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s007lbl.pdf [^4]: Drugs@FDA: Apokyn (apomorphine) injection, application 021264 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021264 [^5]: Drugs@FDA: Onapgo (apomorphine) infusion, application 214056 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214056 [^6]: Drugs@FDA: Kynmobi (apomorphine) sublingual film, application 210875 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210875 [^7]: Federal Register: withdrawal of approval of 12 new drug applications, Kynmobi among them, 2025 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 [^8]: Federal Register: advisory subcommittee meeting on an apomorphine tablet for erectile dysfunction, 2000 https://www.federalregister.gov/documents/2000/03/02/00-4947/urology-subcommittee-of-the-advisory-committee-for-reproductive-health-drugs-notice-of-meeting [^9]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act [^10]: FDA: 503A bulk drug substances category list https://www.fda.gov/media/94155/download [^11]: 21 CFR 1308.12: Schedule II, opiates excluding apomorphine https://www.ecfr.gov/current/title-21/section-1308.12 [^12]: FDA: understanding the risks of compounded drugs https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs [^13]: Randomized trial: apomorphine shots for "off" episodes in Parkinson's disease, 2001 https://pubmed.ncbi.nlm.nih.gov/11559309/ [^14]: Randomized phase 3 trial: apomorphine sublingual film for "off" episodes, 2020 https://pubmed.ncbi.nlm.nih.gov/31818699/ [^15]: Randomized trial (TOLEDO): apomorphine infusion in Parkinson's disease, 2018 https://pubmed.ncbi.nlm.nih.gov/30055903/ [^16]: Randomized thorough QT study of apomorphine sublingual film in Parkinson's disease, 2022 https://pubmed.ncbi.nlm.nih.gov/35899977/ [^17]: Systematic review and meta-analysis: apomorphine for erectile dysfunction, 2020 https://pubmed.ncbi.nlm.nih.gov/32964351/ [^18]: Randomized crossover trial: sublingual apomorphine against sildenafil, 2008 https://pubmed.ncbi.nlm.nih.gov/18405767/ [^19]: Rat study: apomorphine, dopamine signaling in the brain and erection, 1999 https://pubmed.ncbi.nlm.nih.gov/10379793/ [^20]: ClinicalTrials.gov NCT07219927: patient experience with apomorphine infusion in the US https://clinicaltrials.gov/study/NCT07219927 [^21]: Pharmaceutical Technology: FDA approves an apomorphine infusion pump, February 2025 https://www.pharmaceutical-technology.com/newsletters/supernus-wins-fda-approval-for-parkinsons-pump-on-fourth-try