Last reviewed 2026-05-24 · How we verify

Continuous Subcutaneous Lisuride Infusion

Axxonis Pharma AG · Phase 3 active Small molecule ✓ Verified May 2026

Continuous Subcutaneous Lisuride Infusion is a Dopamine agonist Small molecule drug developed by Axxonis Pharma AG. It is currently in Phase 3 development for Parkinson's disease with motor fluctuations and dyskinesias.

Lisuride is a dopamine agonist that activates dopamine receptors to improve motor symptoms and reduce involuntary movements in Parkinson's disease.

Continuous Subcutaneous Lisuride Infusion is a treatment for Parkinson's Disease. It involves the continuous subcutaneous infusion of lisuride, a medication that has been studied in clinical trials.

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	Continuous Subcutaneous Lisuride Infusion
Sponsor	Axxonis Pharma AG
Drug class	Dopamine agonist
Target	D1 and D2 dopamine receptors
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 3

Mechanism of action

Lisuride acts as a non-ergot dopamine agonist, binding to D2 and D1 dopamine receptors in the brain. By stimulating these receptors, it compensates for the loss of dopamine-producing neurons characteristic of Parkinson's disease, thereby reducing motor fluctuations and dyskinesias. Continuous subcutaneous infusion allows for steady-state dopamine receptor stimulation, potentially reducing the on-off motor fluctuations associated with oral or intermittent dosing.

Approved indications

Parkinson's disease with motor fluctuations and dyskinesias

Common side effects

Nausea
Dizziness
Hypotension
Hallucinations
Injection site reactions

Key clinical trials

Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion (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:

Continuous Subcutaneous Lisuride Infusion CI brief — competitive landscape report
Continuous Subcutaneous Lisuride Infusion updates RSS · CI watch RSS
Axxonis Pharma AG portfolio CI

Frequently asked questions about Continuous Subcutaneous Lisuride Infusion

What is Continuous Subcutaneous Lisuride Infusion?

Continuous Subcutaneous Lisuride Infusion is a Dopamine agonist drug developed by Axxonis Pharma AG, indicated for Parkinson's disease with motor fluctuations and dyskinesias.

How does Continuous Subcutaneous Lisuride Infusion work?

Lisuride is a dopamine agonist that activates dopamine receptors to improve motor symptoms and reduce involuntary movements in Parkinson's disease.

What is Continuous Subcutaneous Lisuride Infusion used for?

Continuous Subcutaneous Lisuride Infusion is indicated for Parkinson's disease with motor fluctuations and dyskinesias.

Who makes Continuous Subcutaneous Lisuride Infusion?

Continuous Subcutaneous Lisuride Infusion is developed by Axxonis Pharma AG (see full Axxonis Pharma AG pipeline at /company/axxonis-pharma-ag).

What drug class is Continuous Subcutaneous Lisuride Infusion in?

Continuous Subcutaneous Lisuride Infusion belongs to the Dopamine agonist class. See all Dopamine agonist drugs at /class/dopamine-agonist.

What development phase is Continuous Subcutaneous Lisuride Infusion in?

Continuous Subcutaneous Lisuride Infusion is in Phase 3.

What are the side effects of Continuous Subcutaneous Lisuride Infusion?

Common side effects of Continuous Subcutaneous Lisuride Infusion include Nausea, Dizziness, Hypotension, Hallucinations, Injection site reactions.

What does Continuous Subcutaneous Lisuride Infusion target?

Continuous Subcutaneous Lisuride Infusion targets D1 and D2 dopamine receptors and is a Dopamine agonist.

Drug class: All Dopamine agonist drugs
Target: All drugs targeting D1 and D2 dopamine receptors
Manufacturer: Axxonis Pharma AG — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Parkinson's disease with motor fluctuations and dyskinesias

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