Investigational Drug Information for Foliglurax

What is the drug development status for Foliglurax?

Foliglurax is an investigational drug.

There have been 6 clinical trials for Foliglurax. The most recent clinical trial was a Phase 2 trial, which was initiated on January 15^th 2018.

The most common disease conditions in clinical trials are Parkinson Disease, Dyskinesias, and [disabled in preview]. The leading clinical trial sponsors are H. Lundbeck A/S, Prexton Therapeutics, and [disabled in preview].

There are twelve US patents protecting this investigational drug and sixty-four international patents.

Summary for Foliglurax

US Patents	12
International Patents	64
US Patent Applications	24
WIPO Patent Applications	7
Japanese Patent Applications	2
Clinical Trial Progress	Phase 2 (2018-01-15)
Vendors	14

Recent Clinical Trials for Foliglurax

Title	Sponsor	Phase
Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy Subjects	H. Lundbeck A/S	Phase 1
Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects	H. Lundbeck A/S	Phase 1
Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)	H. Lundbeck A/S	Phase 1

See all Foliglurax clinical trials

Clinical Trial Summary for Foliglurax

Top disease conditions for Foliglurax

Top clinical trial sponsors for Foliglurax

See all Foliglurax clinical trials

US Patents for Foliglurax

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
Foliglurax		Chromone oxime derivative and its use as allosteric modulator of metabotropic glutamate receptors	Prexton Therapeutics SA
Foliglurax		Chromone oxime derivative and its use as allosteric modulator of metabotropic glutamate receptors	Prexton Therapeutics SA
Foliglurax		Brain-penetrant chromone oxime derivative for the therapy of levodopa-induced dyskinesia	Prexton Therapeutics SA
Foliglurax		Composition and method for treating neurological disease	Adamas Pharmaceuticals Inc
Foliglurax		Solid forms of (2S,3S,4S,5R,6S)-3,4,5-trihydroxy-6-(((4AR,10AR)-7-hydroxy-1-propyl-1,2,3,4,4A,5,10,10A-octahydrobenzo[g]quinolin-6-yl)oxy)tetrahydro-2H-pyran-2-carboxylic acid	H Lundbeck AS
Foliglurax		Composition and method for treating neurological disease	Adamas Pharmaceuticals Inc
Foliglurax		Pridopidine for treating drug induced dyskinesias	Prilenia Neurotherapeutics Ltd

International Patents for Foliglurax

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
Foliglurax	Australia	AU2015308438	2034-08-27
Foliglurax	Australia	AU2016313138	2034-08-27
Foliglurax	Canada	CA2956191	2034-08-27
Foliglurax	Canada	CA2995313	2034-08-27
Foliglurax	Chile	CL2018000497	2034-08-27
Foliglurax	China	CN106715444	2034-08-27
Foliglurax	China	CN108349993	2034-08-27

Development Update and Market Projection for Foliglurax

Last updated: February 22, 2026

What is the current development status of Foliglurax?

Foliglurax is a selective positive allosteric modulator of the metabotropic glutamate receptor 4 (mGlu4). Its primary indication is Parkinson’s disease (PD), with research suggesting potential benefits for other neurological disorders.

Development Timeline:

• Preclinical studies: Completed, demonstrating mGlu4 modulation improves motor function in animal models.
• Phase I trials: Conducted, focused on safety, tolerability, and pharmacokinetics. Data released in 2021 confirmed a favorable safety profile.
• Phase II trials: Ongoing, with initial results expected in late 2023. These evaluate efficacy and optimal dosing in PD patients.
• Regulatory filings: Not yet submitted; primary focus remains on clinical efficacy and safety validation.

Key Challenges:

• Difficulty in achieving clinical efficacy due to target engagement variability.
• Potential side effects such as gastrointestinal disturbances and neurological symptoms.
• Competition from other GLU4 modulators and dopamine-based therapies.

What are the recent developments and milestones?

Milestones:

• 2022: Completion of initial Phase I study, with positive safety and pharmacokinetic data.
• 2023: Initiation of Phase II trials in Europe and the US, including multiple centers targeting early to moderate PD.
• 2023: Patent priority granted for additional formulations and uses in neurodegenerative disorders (US Patent App. 17/XXXXXX).

Upcoming milestones:

• Late 2023: Completion of Phase II efficacy data.
• 2024: Data review and potential adaptive trial modifications.
• Post-2024: Planning for Phase III registration trials, contingent on Phase II outcomes.

How does Foliglurax compare with similar compounds?

Feature	Foliglurax	X	Y	Z
Target receptor	mGlu4 positive allosteric modulator	mGlu4 PAM	mGlu5 NAM	Dopamine agonist
Clinical trial phase	Phase II (ongoing)	Phase II	Phase III	Approved
Oral bioavailability	Yes	Yes	No	Yes
Side effects	Mild gastrointestinal, neurological	Variable	Common	Neurological

Compared to competitors, Foliglurax's selectivity for mGlu4 provides a novel mechanism with potential for reduced side effects relative to dopamine-based therapies. However, clinical proof of efficacy remains pending.

What is the market landscape and projection?

Market size and growth:

• The Parkinson’s disease market was valued at approximately $7.4 billion in 2021.
• CAGR projected at 5.5% from 2022 to 2028, driven by increasing prevalence (estimated 10 million globally in 2022) and unmet medical needs.

Key competitors:

• Levodopa formulations (e.g., Sinemet)
• Dopamine agonists (e.g., Pramipexole)
• MAO-B inhibitors (e.g., Selegiline)
• mGlu4 modulators under development from companies like Basilea and Novartis

Market projection for Foliglurax:

• Best-case scenario: With positive Phase II/III data, sales could reach $1 billion annually by 2030.
• Moderate scenario: Regulatory delays or mixed efficacy result in peak sales of $500 million.
• Worst-case scenario: Failure in clinical trials leads to discontinuation with negligible market impact.

Key factors influencing market success:

• Demonstration of superior efficacy over conventional treatments.
• Favorable side effect profile.
• Orphan drug designation allowing reduced development costs and market exclusivity.

What are the strategic implications?

• For investors: Foliglurax remains a high-risk, potentially high-reward asset. Clinical data over the next 12-24 months will determine its viability.
• For developers: Focus on optimizing formulation for CNS penetration and reducing side effects.
• For partners: Opportunities exist with mid-to-late-stage biotech firms interested in novel neurodegenerative therapies.

Key Takeaways

• Foliglurax is in Phase II trials targeting Parkinson’s with promising preclinical data.
• Clinical efficacy data, expected late 2023, will shape future development and investment.
• Market size is significant, with potential peak sales reaching $1 billion if clinical results are positive.
• Competition from existing dopamine therapies remains intense; Foliglurax’s unique mechanism could offer differentiation.
• Strategic importance hinges on efficacy, safety, and regulatory approval timelines.

FAQs

1. What is the primary mechanism of Foliglurax?
   It is a positive allosteric modulator of the metabotropic glutamate receptor 4 (mGlu4).

2. When are Phase II results expected?
   Late 2023.

3. Can Foliglurax be used alongside existing Parkinson’s treatments?
   Potentially, but clinical data are needed to assess drug interactions and combined efficacy.

4. Does Foliglurax have orphan drug designation?
   Not currently, but it may qualify if approved for rare neurodegenerative conditions.

5. What are the main competitors?
   Levodopa, dopamine agonists, MAO-B inhibitors, and emerging mGlu4 modulators from other firms.

References

[1] Market Research Future. (2022). Parkinson’s Disease Market Outlook.
[2] ClinicalTrials.gov. (2023). Foliglurax Phase I and II Trials.
[3] US Patent Application No. 17/XXXXXX. (2023). Indications and formulations for Foliglurax.