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apomorphine infusion
apomorphine infusion is a Small molecule drug developed by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals. It is currently in Phase 3 development.
Apomorphine infusion is a treatment for Parkinson's disease and other conditions, such as brain injury, and is administered through continuous subcutaneous infusion. It works by acting as a D2-like dopamine receptor agonist, a type of small molecule that stimulates these receptors.
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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).
| 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 infusion |
|---|---|
| Sponsor | MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
- Infusion site nodule
- Nausea
- Somnolence
- Infusion site erythema
- Dyskinesia
- Insomnia
- Dizziness
- Headache
- Infusion site haematoma
- Vomiting
- Oedema peripheral
- Nasopharyngitis
Key clinical trials
- Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States:
- Infusion of Apomorphine: Long-term Safety Study (PHASE3)
- Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease (PHASE4)
- Apomorphine in Severe Brain-injured Patients (PHASE2, PHASE3)
- Personality and Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease
- Treatment of Apomorphine-induced Skin Reactions: a Pilot Study (PHASE2)
- Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (PHASE3)
- Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals (NA)
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 infusion CI brief — competitive landscape report
- apomorphine infusion updates RSS · CI watch RSS
- MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals portfolio CI
Frequently asked questions about apomorphine infusion
What is apomorphine infusion?
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What development phase is apomorphine infusion in?
What are the side effects of apomorphine infusion?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing