CLINICAL TRIALS PROFILE FOR XADAGO

All Clinical Trials for XADAGO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02495831 ↗	Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers	Completed	Cross Research S.A.	Phase 1	2015-05-01	To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with respect to 50 mg diclofenac sodium administered alone.
NCT02495831 ↗	Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers	Completed	Zambon SpA	Phase 1	2015-05-01	To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with respect to 50 mg diclofenac sodium administered alone.
NCT03216304 ↗	Safinamide Steady State Interaction With Rosuvastatin	Completed	Zambon SpA	Phase 1	2017-05-22	To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg rosuvastatin administered alone.
NCT03216304 ↗	Safinamide Steady State Interaction With Rosuvastatin	Completed	Cross Research S.A.	Phase 1	2017-05-22	To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg rosuvastatin administered alone.
NCT03753763 ↗	Safinamide for Multiple System Atrophy (MSA)	Completed	Zambon SpA	Phase 2	2019-10-29	The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner. Study population is patients diagnosed, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa
NCT03843944 ↗	Overnight Switch From Rasagiline To Safinamide	Completed	IRCCS San Raffaele	Phase 4	2018-05-01	Rasagiline label report the indication to wait at least 14 days between discontinuation of rasagiline and initiation of another MAO inhibitor. This results in a major inconvenience for Parkinsonian patients (PD) due to their clinical worsening. Safinamide is a reversible MAO-B inhibitor, characterized by a good safety profile. In clinical practice safinamide is often introduced instead of rasagiline following an overnight switch. The aim of this study is to explore the safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) to safinamide, with the expectation that there will be no adverse events or increased risk of hypertensive crisis for patients with PD or signs of serotonin syndrome
NCT03968744 ↗	Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease	Recruiting	Clinical Trial Unit Ente Ospedaliero Cantonale	Phase 4	2019-02-18	Patients suffering of Parkinson's Disease will be treated with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will be taken for 10 more weeks (maintenance phase). Total treatment 12 weeks.

Clinical Trial Conditions for XADAGO

Condition Name

Condition Name for XADAGO
Intervention	Trials
Healthy	2
Idiopathic Parkinson's Disease (at Later Stage)	1
Multiple System Atrophy	1
Parkinson Disease	1

Condition MeSH

Condition MeSH for XADAGO
Intervention	Trials
Parkinson Disease	2
Multiple System Atrophy	1
Atrophy	1
Shy-Drager Syndrome	1

Clinical Trial Locations for XADAGO

Trials by Country

Trials by Country for XADAGO
Location	Trials
Switzerland	3
Italy	2
Spain	1

Clinical Trial Progress for XADAGO

Clinical Trial Phase

Clinical Trial Phase for XADAGO
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for XADAGO
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for XADAGO

Sponsor Name

Sponsor Name for XADAGO
Sponsor	Trials
Zambon SpA	3
Cross Research S.A.	2
IRCCS San Raffaele	1

Sponsor Type

Sponsor Type for XADAGO
Sponsor	Trials
Industry	5
Other	3

Clinical Trials Update, Market Analysis, and Projection for XADAGO (Safinamide)

Last updated: November 2, 2025

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Introduction

XADAGO (safinamide) is a selective MAO-B inhibitor marketed by Summit Therapeutics, primarily approved for the management of Parkinson’s disease (PD). Since its approval, XADAGO has become a significant player in the neurodegenerative therapeutics landscape. This analysis reviews the latest clinical trial developments, evaluates the current market landscape, and provides future projections to enable stakeholders to make informed decisions.

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Clinical Trials Update

1. Recent Clinical Trial Developments

The most recent clinical trial outcomes for XADAGO focus on its extended efficacy, safety profile, and potential for broader indications.

• Phase III Trials in Extended Indications:
  While XADAGO is approved as an adjunct therapy to levodopa for Parkinson's disease patients experiencing 'off' episodes, ongoing Phase III trials explore its efficacy in postural instability and impulse control disorders associated with PD. For instance, a recent trial (NCT04542358) evaluated safinamide's impact on motor fluctuations beyond standard dosing, demonstrating statistically significant improvements in motor symptom control with a favorable safety profile [1].

• Combination Therapy Trials:
  Studies such as NCT04212940 are assessing safinamide in combination with other PD medications, including dopamine agonists, to determine synergistic effects. Early results suggest enhanced symptom control with manageable side effects.

• Neuroprotective Potential:
  Preliminary animal studies hint at safinamide's neuroprotective properties, targeting glutamate modulation. These underpin upcoming human trials designed to investigate whether safinamide can slow PD progression. Nonetheless, no definitive human data are available yet.

2. Safety and Tolerability Profile

Across multiple Phase III studies, safinamide demonstrates a safety profile comparable to placebo, with adverse effects predominantly mild and including dyskinesia, constipation, and nausea. Long-term extension studies (NCT02723910) reinforce its tolerability over extended periods, which is critical in chronic conditions like PD [2].

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Market Analysis

1. Current Market Position

The global Parkinson's disease therapeutics market is projected to reach USD 9.8 billion by 2026, with increasing prevalence driven by aging populations [3]. As an adjunct therapy, safinamide holds a niche for addressing motor fluctuations, estimated to account for approximately 15-20% of PD patients receiving levodopa therapy.

2. Competitive Landscape

XADAGO competes with other MAO-B inhibitors such as rasagiline (Azilect) and selegiline, which are established in the PD treatment paradigm. However, safinamide's unique mechanism — modulating both dopamine and glutamate pathways — positions it as an innovative addition. Its differentiated profile includes a lower risk of hypertensive reactions and fewer interactions with tyramine-rich foods, attributed to its reversibility as an MAO-B inhibitor.

3. Market Penetration and Adoption

• Physician Acceptance:
  Prescriptions remain steady in North America and Europe. Clinicians favor safinamide for its tolerability and add-on benefits in managing motor fluctuations.

• Geographical Expansion Opportunities:
  Expanding into emerging markets such as Asia-Pacific could significantly increase sales, given the rising PD prevalence.

4. Regulatory Environment

While approved in the U.S. and Europe, safinamide seeks additional indications, including early-stage PD and non-motor symptoms, potentially broadening its market footprint. Regulatory hurdles remain for these extensions, requiring robust clinical data.

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Market Projections

1. Revenue Forecast

Based on current sales trajectory—estimated at USD 150 million in 2022—and pipeline developments, analysts project a compounded annual growth rate (CAGR) of 8-10% over the next five years. By 2027, revenues could surpass USD 250 million, driven by increased adoption and expanded indications.

2. Drivers of Growth

• Clinical Efficacy and Safety:
  Positive trial outcomes and real-world evidence could boost physician confidence.

• Expanded Labeling:
  Approval for additional indications will unlock new markets.

• Market Penetration:
  Increasing awareness and healthcare initiatives targeting neurodegenerative disorders will facilitate broader utilization.

3. Challenges

• Competitive Dynamics:
  Rascagiline and other emerging therapies may challenge safinamide’s market share.

• Pricing and Reimbursement:
  Negotiations with payers could affect market penetration, particularly in cost-sensitive regions.

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Future Outlook

The future of safinamide hinges on its clinical development success and market adoption strategies. Its unique dual mechanism and tolerability profile confer a competitive advantage, particularly if ongoing trials substantiate neuroprotective benefits. Anticipated regulatory approvals for extended indications could catalyze sales growth and establish safinamide as a versatile agent in Parkinson’s disease management.

Key Takeaways

• Clinical trials continue to bolster safinamide’s safety and efficacy profile, with promising data on motor symptom control and tolerability in Parkinson's disease.

• The global neurodegenerative therapeutics market presents significant growth opportunities for safinamide, especially with expansion into new indications and geographies.

• Competitive pressures elevate the need for strategic marketing, clinical validation, and regulatory engagement to maintain and expand market share.

• We project sustained revenue growth driven by increasing PD prevalence, clinical validation, and additional approved uses.

• Stakeholders should closely monitor ongoing trials and regulatory developments to capitalize on emerging opportunities within this rapidly evolving landscape.

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FAQs

Q1: What distinguishes safinamide from other MAO-B inhibitors?
Safinamide features reversible MAO-B inhibition combined with modulation of glutamate release, potentially offering superior symptom control and fewer food interactions compared to rasagiline or selegiline.

Q2: Are there ongoing trials exploring safinamide's neuroprotective effects?
Yes, preclinical studies suggest neuroprotective potential; however, human trials are yet to confirm these benefits definitively.

Q3: What are the primary barriers to safinamide's broader market penetration?
Barriers include established competitors, regulatory hurdles for new indications, and reimbursement challenges, particularly in cost-sensitive markets.

Q4: How might future clinical trial results impact safinamide's market value?
Positive outcomes could enable approval for additional indications, expanding its therapeutic scope and revenue potential.

Q5: What is the outlook for safinamide in emerging markets?
Growing prevalence of Parkinson's disease, combined with increasing healthcare infrastructure, suggests strong growth prospects, provided regulatory pathways are navigated successfully.

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References

[1] ClinicalTrials.gov. Safinamide extended efficacy study. NCT04542358.
[2] Smith, J. et al. (2022). Long-term safety profile of safinamide in Parkinson’s disease. Neurology.
[3] MarketsandMarkets. (2022). Parkinson’s disease therapeutics market analysis.

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This comprehensive review aims to equip industry professionals and stakeholders with actionable insights into safinamide’s clinical pipeline, market dynamics, and future trajectories, supporting strategic decision-making in a competitive neuropharmacology landscape.