Apomorphine

Overview

Apomorphine is a non-ergoline dopamine D2 agonist indicated to treat hypomobility associated with Parkinson's. It was first synthesized in 1845 and first used in Parkinson's disease in 1884. Apomorphine has also been investigated as an emetic, a sedative, a treatment for alcoholism, and a treatment of other movement disorders. Apomorphine was granted FDA approval on 20 April 2004.

Indication

Apomorphine is indicated to treat acute, intermittent treatment of hypomobility, off episodes associated with advanced Parkinson's disease.

Associated Conditions

Mobility decreased

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes	2023/08/07	NCT05979415	Phase 2	Terminated	Alexza Pharmaceuticals, Inc.
Sublingual Apomorphine in Refractory Restless Legs Syndrome	2022/09/06	NCT05529095	Phase 4	Not yet recruiting	William Ondo, MD
Apomorphine in Severe Brain-injured Patients	2022/01/28	NCT05213169	Phase 2	Recruiting	University of Liege
Motor Network Physiology	2021/07/12	NCT04957095	Not Applicable	Recruiting	University of Texas Southwestern Medical Center
Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease	2021/05/14	NCT04887467	Phase 4	Completed	Rennes University Hospital
Apomorphine Effects on Pain in Parkinson's Disease	2021/05/10	NCT04879134	Phase 2	UNKNOWN	University of Calgary
Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)	2021/03/08	NCT04786158	N/A	Completed	Fondation Ophtalmologique Adolphe de Rothschild
Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals	2018/10/03	NCT03693872	Not Applicable	Completed	Rennes University Hospital
Treating Severe Brain-injured Patients With Apomorphine	2018/08/09	NCT03623828	Phase 2	UNKNOWN	University of Liege
A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)	2018/01/05	NCT03391882	Phase 3	Completed	Sumitomo Pharma America, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
APOKYN	MDD US Operations, LLC	27505-004	SUBCUTANEOUS	30 mg in 3 mL	12/20/2023
ONAPGO	MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc	27505-006	SUBCUTANEOUS	4.9 mg in 1 mL	7/7/2025
apomorphine hydrocloride	TruPharma, LLC	52817-720	SUBCUTANEOUS	30 mg in 3 mL	2/24/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Apomorphine Hydrochloride Sublingual Tablets	湖北科益药业股份有限公司	国药准字H20050969	化学药品	片剂	8/31/2020
Apomorphine Hydrochloride Sublingual Tablets	湖北科益药业股份有限公司	国药准字H20050970	化学药品	片剂	8/31/2020
Apomorphine Hydrochloride Injection	东北制药集团沈阳第一制药有限公司	国药准字H21022435	化学药品	注射剂	7/13/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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