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AFQ056 with L-dopa
AFQ056 with L-dopa is a mGluR5 negative allosteric modulator Small molecule drug developed by Novartis. It is currently in Phase 2 development for Parkinson's disease with motor complications (dyskinesias and motor fluctuations).
AFQ056 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator that reduces excessive glutamatergic signaling, combined with L-dopa to enhance dopaminergic activity in Parkinson's disease.
AFQ056 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator that reduces excessive glutamatergic signaling, combined with L-dopa to enhance dopaminergic activity in Parkinson's disease. Used for Parkinson's disease with motor complications (dyskinesias and motor fluctuations).
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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). -
Big-pharma sponsor
+3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | AFQ056 with L-dopa |
|---|---|
| Sponsor | Novartis |
| Drug class | mGluR5 negative allosteric modulator |
| Target | mGluR5 (metabotropic glutamate receptor 5) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
AFQ056 selectively blocks mGluR5 receptors on the postsynaptic side of glutamatergic synapses, reducing excitotoxic glutamate signaling that contributes to motor complications in Parkinson's disease. When combined with L-dopa (levodopa), the mGluR5 inhibition may enhance dopaminergic efficacy and reduce dyskinesias and motor fluctuations. This combination approach targets both the dopamine deficit and the secondary glutamatergic dysfunction characteristic of advanced Parkinson's disease.
Approved indications
- Parkinson's disease with motor complications (dyskinesias and motor fluctuations)
Common side effects
- Dizziness
- Nausea
- Headache
- Somnolence
Key clinical trials
- Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias (PHASE2)
- Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia (PHASE2)
- Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias (PHASE2)
- Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias (PHASE2)
- Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias (PHASE2)
- Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease (PHASE2)
- Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients (PHASE2)
- Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa (PHASE2)
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:
- AFQ056 with L-dopa CI brief — competitive landscape report
- AFQ056 with L-dopa updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about AFQ056 with L-dopa
What is AFQ056 with L-dopa?
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Related
- Drug class: All mGluR5 negative allosteric modulator drugs
- Target: All drugs targeting mGluR5 (metabotropic glutamate receptor 5)
- Manufacturer: Novartis — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Parkinson's disease with motor complications (dyskinesias and motor fluctuations)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing