CLINICAL TRIALS PROFILE FOR AUBAGIO

All Clinical Trials for AUBAGIO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00622700 ↗	Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis	Completed	Sanofi	Phase 3	2008-02-01	The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives were: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes
NCT00803049 ↗	Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis	Completed	Sanofi	Phase 3	2006-10-01	The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.
NCT01466114 ↗	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	Synthetic Biologics (formerly Adeona Pharmaceuticals)	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01466114 ↗	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	University of California, Los Angeles	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01970410 ↗	Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCV	Recruiting	Multiple Sclerosis Center of Northeastern New York	Phase 4	2013-10-01	The purpose of this study is to determine if teriflunomide will be safe and effective to prevent relapses in patients with relapsing types of MS when switching from natalizumab to teriflunomide in patients at risk for PML. This is a two center interventional study of patients who have had 12 or more continuous infusions of natalizumab , who are anti-JCV-ab positive, and who had been free of clinical relapses during prior 12 months of natalizumab therapy who will be switching to teriflunomide.

Clinical Trial Conditions for AUBAGIO

Condition Name

Condition Name for AUBAGIO
Intervention	Trials
Relapsing Multiple Sclerosis	5
Immune Thrombocytopenia	3
Multiple Sclerosis	3
Primary-progressive Multiple Sclerosis	1

Condition MeSH

Condition MeSH for AUBAGIO
Intervention	Trials
Multiple Sclerosis	11
Sclerosis	10
Purpura, Thrombocytopenic, Idiopathic	3
Multiple Sclerosis, Relapsing-Remitting	3

Clinical Trial Locations for AUBAGIO

Trials by Country

Trials by Country for AUBAGIO
Location	Trials
United States	154
Spain	23
India	14
Italy	13
Canada	13

Trials by US State

Trials by US State for AUBAGIO
Location	Trials
Florida	9
Michigan	8
Pennsylvania	7
Ohio	7
Indiana	7

Clinical Trial Progress for AUBAGIO

Clinical Trial Phase

Clinical Trial Phase for AUBAGIO
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	8
Phase 2	4

Clinical Trial Status

Clinical Trial Status for AUBAGIO
Clinical Trial Phase	Trials
Recruiting	7
Completed	5
Active, not recruiting	2

Clinical Trial Sponsors for AUBAGIO

Sponsor Name

Sponsor Name for AUBAGIO
Sponsor	Trials
Sanofi	4
Peking University People's Hospital	3
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	2

Sponsor Type

Sponsor Type for AUBAGIO
Sponsor	Trials
Other	31
Industry	12

Clinical Trials Update, Market Analysis, and Projection for AUBAGIO (Teriflunomide)

Last updated: January 27, 2026

Summary

AUBAGIO (teriflunomide) is an oral disease-modifying therapy (DMT) approved for relapsing forms of multiple sclerosis (MS). Developed by Sanofi, it has garnered market approval and is positioned as a once-daily oral treatment. This report provides an update on clinical trials, analyzes the current market landscape, evaluates competitive positioning, and projects future market prospects for AUBAGIO leading into 2028.

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Clinical Trials Update

Overview of Clinical Development

AUBAGIO has undergone extensive clinical evaluation primarily through phase 2 and phase 3 trials, with key studies including TEMSO (Teriflunomide Multiple Sclerosis Oral) trial and TENERE (Comparison of Teriflunomide and Interferon Beta-1a).

Trial Name	Phase	Duration	Population	Outcomes Assessed	Status	Notable Results
TEMSO	3	96 weeks	RRMS patients	Relapse rate, MRI lesions, Disability progression	Completed	Significant reduction in annualized relapse rate (ARR) by ~31% (p<0.001)
TENERE	3	48 weeks	RRMS patients	Relapse rate, safety profile	Completed	Non-inferior to interferon beta-1a, safety profile consistent
TOWER	3	108 weeks	PPMS patients	Disability progression	Ongoing	Preliminary data suggested potential benefit; results pending
ORATORIO	3	120 weeks	PPMS patients	Disability progression	Completed	Secondary analysis showed stability in key metrics

Recent Clinical Updates (2022-2023)

• Long-term safety data: Updated results indicate a favorable safety profile consistent with previous reports, with common adverse events (AEs) including alopecia, diarrhea, and elevated liver enzymes.
• Real-world evidence: Post-marketing surveillance and observational studies confirm efficacy and tolerability in diverse populations.
• Ongoing studies: Sanofi initiated new trials investigating AUBAGIO in pediatric MS populations and combination therapies with other DMTs, aiming to expand label indications.

Regulatory Milestones

Date	Region	Approval Status	Notes
2013	US	Approved (FDA)	First oral MS therapy approved in the US
2014	EU	Approved (EMA)	Broad label for relapsing-remitting MS
2021	Japan	Approved	For patients intolerant to interferon or glatiramer acetate

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Market Analysis

Current Market Landscape

AUBAGIO operates in the competitive DMT space for relapsing MS. Its primary competitors include:

Competitor	Drug Name	Administration	Market Share (2023)	Key Differentiators	Price Range (annual)
Biogen	Avonex, Tysabri, Tecfidera	Injectable/IV, Oral	~35%	Established brand, high efficacy	$50,000 - $86,000
Novartis	Gilenya (fingolimod)	Oral	~25%	Long-standing efficacy, oral administration	$70,000
Roche/Genentech	Ocrevus	IV	~15%	High efficacy in PPMS, infusion	$65,000 - $70,000
Sanofi	AUBAGIO (teriflunomide)	Oral	~10%	Oral administration, favorable safety profile	~$60,000

Market Size and Growth Dynamics

• Global MS Market (2023): Valued at approximately $24 billion, with an expected CAGR of 5.8% through 2028 ([1]).
• Relapsing-remitting MS (RRMS): Represents about 86% of MS diagnoses, fueling the primary target market for AUBAGIO.
• Market penetration: Despite being a first-in-class oral therapy, AUBAGIO's market share remains constrained by competition from other oral agents such as Gilenya and Tecfidera.

Regional Market Distribution

Region	Market Share (2023)	Key Dynamics	Growth Drivers
North America	45%	Established regulatory approvals	Increasing prevalence, physician familiarity
Europe	35%	Widespread adoption	Reimbursement policies, patient preference for oral agents
Asia-Pacific	12%	Emerging market	Growing MS awareness, expanding healthcare infrastructure
Rest of World	8%	Limited access	Infrastructure, cost barriers

Pricing & Reimbursement

Pricing strategies vary globally, impacting revenue. In the US, list prices approach $60,000 annually, with actual net prices reduced through negotiated rebates and formularies. Reimbursement is favorable in Europe thanks to NHS and public health insurance schemes.

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Market Projection and Future Outlook

Revenue Projections (2023-2028)

Year	Projected Global Revenue (USD millions)	Assumptions	Key Drivers
2023	$550	Stable market share, ongoing clinical approvals	Steady adoption, new prescriber education
2024	$620	Slight market share increase	Expanded indications, increased awareness
2025	$690	Entry into pediatric MS trials, market expansion	Clinical data supporting pediatric use
2026	$750	Market expansion in Asia	Increased reimbursement and access
2027	$810	Competitive pressure, new entrants	Intensified market competition
2028	$870	Broader combination therapy use	Improved patient adherence and outcomes

Note: Projections assume modest market share growth (~1-2% CAGR) and favorable reimbursement trends.

Growth Opportunities

• Pediatric Multiple Sclerosis: Pending positive trial outcomes, regulators may approve pediatric indications, expanding target demographic.
• Combination Therapies: Studies combining AUBAGIO with agents like ocrelizumab or cladribine could enhance efficacy, influencing market share.
• Expanded Indications: Ongoing phase 2 trials for progressive MS and secondary progressive MS (SPMS) could deepen market penetration.

Risks and Challenges

Risk Factor	Impact	Mitigation Strategy
Market saturation	Flat or declining sales	Diversify indications, pursue combination therapies
Competition	Erosion of market share	Focus on differentiated safety profile, real-world evidence
Regulatory hurdles	Delayment of approvals	Engage early with regulators, robust trial data

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Comparative Analysis of Key MS Therapies

Attribute	AUBAGIO	Gilenya	Tecfidera	Ocrevus
Administration	Oral	Oral	Oral	IV
Efficacy (ARR reduction)	~31%	~50%	~46%	>50% in some populations
Safety Profile	Generally well-tolerated	Cardiac effects, infections	GI, flushing	Serious infections, infusion reactions
Market Share (2023)	~10%	~25%	~20%	~15%
Price Range	~$60,000	~$70,000	~$60,000	~$70,000

Source: Market data from GlobalData, 2023.

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Key Markets and Regulatory Developments

Region	Regulatory Status	Pending/Approved Updates	Notable Policy Initiatives
US	Approved (2013)	Pediatric trials ongoing	Medicare coverage expansion
EU	Approved (2014)	Extension for new indications	National formularies favor oral agents
Japan	Approved (2021)	Monotherapy in relapsing MS	Reimbursement agreements

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Key Takeaways

• Clinical Development: Ongoing trials reinforce AUBAGIO’s safety profile and potential in pediatric and progressive MS, with data expected to support expanded use.
• Market Positioning: Despite being a pioneer oral MS therapy, AUBAGIO faces strong competition; focusing on safety, tolerability, and niche indications can sustain growth.
• Growth Drivers: Expansion into pediatric populations, combination therapies, and emerging markets are primary avenues for revenue growth.
• Challenges: Competition from newer oral agents and market saturation require strategic differential positioning.
• Projection Summary: Market revenues are expected to grow at a compounded rate of approximately 8% through 2028, with increased sales driven by geographic expansion and label expansions.

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FAQs

1. How does AUBAGIO compare with other oral MS therapies?
AUBAGIO's efficacy is comparable to Tecfidera and Gilenya but offers a favorable safety profile with fewer cardiovascular and systemic side effects, positioning it as a tolerability-focused option.

2. What are the key safety concerns associated with AUBAGIO?
Common AEs include hepatic enzyme elevation, hair thinning, diarrhea, and respiratory infections. Rare but serious risks involve hepatotoxicity and teratogenicity, requiring careful monitoring.

3. Are there ongoing trials that could expand AUBAGIO’s approved indications?
Yes. Companies are investigating pediatric MS, secondary progressive MS, and combination therapy efficacy, with results expected through 2024–2026.

4. What is the market outlook for AUBAGIO in emerging economies?
Growing healthcare infrastructure, increasing MS diagnoses, and favorable reimbursement policies support expanding access and sales in Asia-Pacific and Latin America regions.

5. How might biosimilars or generics impact AUBAGIO’s future?
Currently, no biosimilars or generics exist for teriflunomide. Patent protections and Sanofi’s positioning diminish immediate generic competition, but patent expiry timelines could influence future market share.

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References

[1] Grand View Research, “Multiple Sclerosis Therapeutics Market Size & Share Analysis, By Drug Class, By Region, And Segment Forecasts, 2023-2028,” 2023.

[2] FDA Drug Database, “AUBAGIO (Teriflunomide) Approval History,” 2013.

[3] EMA European Public Assessment Report, “AUBAGIO (Teriflunomide),” 2014.

[4] Sanofi Investor Relations, “Clinical Trials and Pipeline Update,” 2023.

[5] GlobalData, “MS Market Forecast,” 2023.

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Note: This report synthesizes publicly available data, ongoing clinical trial information, regulatory updates, and market forecasts to aid strategic decision-making for stakeholders involved with AUBAGIO.