Last reviewed 2026-04-23 · How we verify

apomorphine HCl injection

Mylan Bertek Pharmaceuticals · Phase 3 active Small molecule

apomorphine HCl injection is a Dopamine agonist Small molecule drug developed by Mylan Bertek Pharmaceuticals. It is currently in Phase 3 development for Treatment of advanced Parkinson's disease, Treatment of 'off' episodes in patients with advanced Parkinson's disease.

Apomorphine HCl injection acts as a dopamine agonist, mimicking the action of dopamine in the brain.

Apomorphine HCl injection acts as a dopamine agonist, mimicking the action of dopamine in the brain. Used for Treatment of advanced Parkinson's disease, Treatment of 'off' episodes in patients with advanced Parkinson's disease.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	apomorphine HCl injection
Sponsor	Mylan Bertek Pharmaceuticals
Drug class	Dopamine agonist
Target	Dopamine receptor
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 3

Mechanism of action

Apomorphine HCl injection works by binding to dopamine receptors in the brain, which helps to alleviate symptoms of Parkinson's disease. This binding action triggers a response that helps to restore normal movement and muscle function. By mimicking the action of dopamine, apomorphine HCl injection helps to improve motor function and reduce symptoms of Parkinson's disease.

Approved indications

Treatment of advanced Parkinson's disease
Treatment of 'off' episodes in patients with advanced Parkinson's disease

Common side effects

Nausea
Vomiting
Dizziness
Headache
Orthostatic hypotension

Key clinical trials

Clinical Trial of Intranasal Delivery of NT-301 (PHASE1)
Blinking and Yawning in Epilepsy: The Role of Dopamine (NA)
Motor Network Physiology (NA)
Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) (PHASE4)
Apomorphine Effects on Pain in Parkinson's Disease (PHASE2, PHASE3)
Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease (PHASE2)
Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease (PHASE3)
Extended Long-Term Safety Study of KW-6500 (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

apomorphine HCl injection CI brief — competitive landscape report
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Mylan Bertek Pharmaceuticals portfolio CI

Frequently asked questions about apomorphine HCl injection

What is apomorphine HCl injection?

apomorphine HCl injection is a Dopamine agonist drug developed by Mylan Bertek Pharmaceuticals, indicated for Treatment of advanced Parkinson's disease, Treatment of 'off' episodes in patients with advanced Parkinson's disease.

How does apomorphine HCl injection work?

Apomorphine HCl injection acts as a dopamine agonist, mimicking the action of dopamine in the brain.

What is apomorphine HCl injection used for?

apomorphine HCl injection is indicated for Treatment of advanced Parkinson's disease, Treatment of 'off' episodes in patients with advanced Parkinson's disease.

Who makes apomorphine HCl injection?

apomorphine HCl injection is developed by Mylan Bertek Pharmaceuticals (see full Mylan Bertek Pharmaceuticals pipeline at /company/mylan-bertek-pharmaceuticals).

What drug class is apomorphine HCl injection in?

apomorphine HCl injection belongs to the Dopamine agonist class. See all Dopamine agonist drugs at /class/dopamine-agonist.

What development phase is apomorphine HCl injection in?

apomorphine HCl injection is in Phase 3.

What are the side effects of apomorphine HCl injection?

Common side effects of apomorphine HCl injection include Nausea, Vomiting, Dizziness, Headache, Orthostatic hypotension.

What does apomorphine HCl injection target?

apomorphine HCl injection targets Dopamine receptor and is a Dopamine agonist.

Drug class: All Dopamine agonist drugs
Target: All drugs targeting Dopamine receptor
Manufacturer: Mylan Bertek Pharmaceuticals — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Treatment of advanced Parkinson's disease
Indication: Drugs for Treatment of 'off' episodes in patients with advanced Parkinson's disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing