Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
Completed
Takeda
Phase 3
2009-03-01
The purpose of this study is to determine the safety and effectiveness of adding alogliptin,
once daily (QD), compared to glipizide with metformin in diabetic patients.
Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes
Completed
AstraZeneca
Phase 1
2012-07-01
The purpose of this study is to assess the effect of roflumilast plus alogliptin on
glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.
Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes
Completed
Takeda
Phase 1
2012-07-01
The purpose of this study is to assess the effect of roflumilast plus alogliptin on
glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
Completed
Takeda
2010-07-08
The purpose of this study is to determine the safety and efficacy of long-term treatment with
alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to
diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy,
and α-glucosidase inhibitor.
In addition, examining the safety and efficacy of alogliptin in patients with renal
impairment, information on the appropriate dosage of alogliptin according to the severity of
impaired renal function should be collected.
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
Completed
Takeda
2011-03-01
The purpose of this study is to determine the safety and efficacy of long-term combination
therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes
mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to
diet therapy and exercise therapy.
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Clinical Trials Update, Market Analysis, and Projection for Nesina (alogliptin)
Last updated: January 27, 2026
Executive Summary
Nesina (alogliptin), developed by Takeda Pharmaceutical Company, is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor approved for type 2 diabetes mellitus (T2DM). This report provides an in-depth analysis of recent clinical trial updates, current market positioning, competitive landscape, and future growth projections.
Monitoring cardiovascular outcomes; preliminary data suggest neutral CV risk
Combination Trials
Phase 3
Nesina + SGLT2 inhibitors
1,500 patients
Recruiting
Aimed at assessing combination efficacy; expected completion in 2024
Renal Impairment Trial
Phase 2
Safety in CKD patients
300 patients
Completed (2021)
Indicated safety but recommended dose adjustments in severe cases
Key Points from Clinical Data
Efficacy: Consistent HbA1c reduction (~0.6–0.8%) across trials.
Safety Profile: Generally well-tolerated; adverse events comparable to placebo, mainly mild gastrointestinal issues.
Cardiovascular Safety: Current data indicates CV neutrality, aligning with DPP-4 class standards.
Renal Safety: No significant renal adverse effects; dosage adjustments necessary in CKD stages 3 and 4.
Market Analysis
Global Market Overview
Region
Market Size (USD Billion, 2022)
Growth Rate (CAGR, 2022–2027)
Key Players
North America
4.4
7.2%
Merck (Janumet), Pfizer (Vildagliptin)
Europe
2.3
6.5%
Novo Nordisk, Lilly
Asia-Pacific
8.5
9.1%
Takeda (Nesina), Sinovac, Lupin
Rest of World
1.2
5.8%
Various local manufacturers
Market Drivers and Challenges
Drivers
Challenges
Growing global T2DM prevalence (537 million adults, WHO, 2021)
Competition from other DPP-4 inhibitors (e.g., Januvia, Onglyza)
Favorable safety profile and oral administration
Patent expiration risks (~2025 for Nesina)
Increased adoption of combination therapies
Price sensitivity in emerging markets
Regulatory approvals for combination therapies
Generic erosion, pricing pressures
Competitive Landscape
Drug
Manufacturer
Approval Status
Market Share (2022)
Key Differentiators
Nesina (alogliptin)
Takeda
Approved in US, EU, Japan
~12% (DPP-4 class)
Once-daily oral, favorable safety profile
Januvia (sitagliptin)
Merck
Globally approved
~35%
Largest DPP-4 market share
Onglyza (saxagliptin)
BMS/AstraZeneca
Approved
~15%
CV data, combination potential
Trajenta (linagliptin)
Boehringer/Ingelheim
Approved
~10%
No renal dose adjustment needed
Future Market Projections
Sales Forecast (2023–2027)
Year
Expected Global Sales (USD Billion)
Growth Rate (YoY)
2023
$1.2
12%
2024
$1.35
12.5%
2025
$1.55
15%
2026
$1.8
16.1%
2027
$2.1
16.6%
Factors Influencing Growth
Market Penetration: Nesina’s approval in additional markets (e.g., China, India) expected to boost sales.
Combination Therapy Approvals: Pending or recent approvals for fixed-dose combinations (FDCs) with SGLT2 inhibitors (e.g., Takeda's Qtern).
Indications Expansion: Potential research into Nesina's efficacy in pre-diabetes or obesity—though not yet approved.
Patent and Exclusivity: US patent expiry around 2025 could accelerate generic entry, impacting pricing and revenue.
Comparison with Competing Drugs
Parameter
Nesina (alogliptin)
Januvia (sitagliptin)
Onglyza (saxagliptin)
Trajenta (linagliptin)
Approval Year
2013
2006
2009
2011
Dosing
25–50 mg daily
25 mg daily
2.5–5 mg daily
5 mg daily
Renal Adjustment
Yes
No
Yes
No
CV Outcomes
Neutral
Neutral
Neutral, CVOTs positive
Neutral
Market Share (2022)
~12%
~35%
~15%
~10%
Regulatory and Policy Landscape
Global Regulatory Developments
FDA (2022): Approved combination of Nesina with empagliflozin for T2DM.
EMA (2021): Extended approval for Nesina in combination therapies.
Japan PMDA (2014): Approved Nesina, now a key player locally.
Pricing and Reimbursement
Pricing varies geographically; the US retail price (~$300/month).
Reimbursement policies increasingly favor oral agents with proven safety.
Patent and Exclusivity Timeline
Patent Expiry
Year
Implication
Primary patent
2025
Increased risk of generic entry post-expiry
Data exclusivity
Up to 2027
Market exclusivity prolongs
Key Takeaways
Clinical Data: Nesina’s relevance remains robust with confirmed efficacy and a favorable safety profile; ongoing CV outcomes trials will influence future positioning.
Market Share and Competition: While Januvia dominates, Nesina's niche as a well-tolerated oral agent positions it for growth, especially through combination therapies.
Growth Opportunities: Expansion into emerging markets, development of fixed-dose combinations, and post-patent strategies are vital.
Strategic Focus: Continued clinical validation, geographic expansion, and operational efficiencies are key to maintaining market relevance.
FAQs
What is the current clinical trial status of Nesina?
Nesina is undergoing ongoing Phase 3 and Phase 4 trials, focusing on cardiovascular outcomes, combination therapies, and safety in special populations.
How does Nesina compare to other DPP-4 inhibitors?
Nesina offers a comparable efficacy and safety profile but distinguishes itself through its once-daily oral administration and ongoing trials for combination therapies.
What are the key patent considerations for Nesina?
The primary patent is scheduled to expire in 2025, exposing Nesina to generic competition, unless additional patents or formulations provide extended exclusivity.
What is the outlook for Nesina’s market share?
Market share is projected to grow modestly, driven by increasing diabetes prevalence, combination therapy approvals, and geographical expansion.
Are there upcoming regulatory changes that could impact Nesina?
Potential approval of new fixed-dose combinations and updates in diabetes management guidelines could positively influence Nesina’s market access and utilization.
References
[1] World Health Organization. Diabetes Fact Sheet, 2021.
[2] Takeda Pharmaceutical. Nesina (alogliptin) Product Information, 2022.
[3] ClinicalTrials.gov. List of Nesina-related Clinical Trials, 2022–2023.
[4] IQVIA. Global Diabetes Therapeutics Market Report, 2022.
[5] FDA. Approved Drugs Database, 2022.
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