CLINICAL TRIALS PROFILE FOR SYNJARDY XR

All Clinical Trials for synjardy xr

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05132023 ↗	Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)	Completed	Hikma Pharma	Phase 1	2019-03-26	Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Empagliflozin & Metformin HCL from Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)
NCT05132023 ↗	Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)	Completed	Genuine Research Center, Egypt	Phase 1	2019-03-26	Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Empagliflozin & Metformin HCL from Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)
NCT06450262 ↗	Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets	COMPLETED	Humanis Saglık Anonim Sirketi	PHASE1	2024-01-04	Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Empagliflozin/ Metformin HCl 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) versus Synjardy® 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin/ 1000mg Metformin HCl) in healthy subjects under fed conditions.
NCT06766500 ↗	Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)	COMPLETED	Gedeon Richter Plc.	PHASE1	2025-01-20	Empagliflozin and metformin hydrochloride are two separate drugs. The combination of these two drugs in one tablet are used for the treatment of type 2 diabetes, along with diet and exercise, and can be used with other drugs, if required. It is approved in Russia and also various other countries. In Russia, the brand name is Synjardy. The purpose of this research study is to measure the amount of the two drugs in the blood after taking two different formulations of the combination tablet. One formulation, also called Synjardy, is an approved product in Russia marketed by Boehringer Ingelheim International GmbH, Germany. The other formulation is an investigational product that is not approved. The data from this study will be used to compare the two products. Subjects participating in this study will take 5 mg empagliflozin and 850 mg metformin hydrochloride (1 combination film-coated tablet) of one formulation in each period. The maximum recommended daily dose is 25 mg of empagliflozin and 2,000 mg of metformin hydrochloride which is based on the subject's current regimen \[prescribed course of medical treatment\], effectiveness, and tolerability.
NCT06792968 ↗	Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany	COMPLETED	Gedeon Richter Plc.	PHASE1	2025-03-30	Empagliflozin and metformin hydrochloride are two separate drugs. The combination of these two drugs in one tablet are used for the treatment of type 2 diabetes, along with diet and exercise, and can be used with other drugs, if required. It is approved in Russia and also various other countries. In Russia, the brand name is Synjardy. The purpose of this research study is to measure the amount of the two drugs in the blood after taking two different formulations of the combination tablet. One formulation, also called Synjardy, is an approved product in Russia marketed by Boehringer Ingelheim International GmbH, Germany. The other formulation is an investigational product that is not approved. The data from this study will be used to compare the two products. Subjects participating in this study will take 5 mg empagliflozin and 1000 mg metformin hydrochloride (1 combination film-coated tablet) of one formulation in each period. The maximum recommended daily dose is 25 mg of empagliflozin and 2,000 mg of metformin hydrochloride which is based on the subject's current regimen, effectiveness, and tolerability.

Clinical Trial Conditions for synjardy xr

Condition Name

Condition Name for synjardy xr
Intervention	Trials
Diabetes Mellitus Type 2	3
Healthy	1
Type2diabetes	1

Condition MeSH

Condition MeSH for synjardy xr
Intervention	Trials
Diabetes Mellitus, Type 2	3
Diabetes Mellitus	3

Clinical Trial Locations for synjardy xr

Trials by Country

Trials by Country for synjardy xr
Location	Trials
Russia	3
Egypt	1
Jordan	1

Clinical Trial Progress for synjardy xr

Clinical Trial Phase

Clinical Trial Phase for synjardy xr
Clinical Trial Phase	Trials
PHASE1	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for synjardy xr
Clinical Trial Phase	Trials
Completed	5

Clinical Trial Sponsors for synjardy xr

Sponsor Name

Sponsor Name for synjardy xr
Sponsor	Trials
Gedeon Richter Plc.	3
Hikma Pharma	1
Genuine Research Center, Egypt	1

Sponsor Type

Sponsor Type for synjardy xr
Sponsor	Trials
Industry	5
Other	1

Clinical Trials Update, Market Analysis and Projection for SYNJARDY XR

Last updated: October 29, 2025

Introduction

SYNJARDY XR (empagliflozin/linagliptin XR) represents a significant evolution in the treatment landscape for type 2 diabetes mellitus (T2DM). Combining the sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, SYNJARDY XR offers a convenient, once-daily therapy designed to optimize glycemic control. This analysis provides an updated overview of ongoing clinical trials, market dynamics, and future growth projections pertinent to SYNJARDY XR.

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Clinical Trials Update

Current Study Landscape

Despite its relatively recent FDA approval in 2019, clinical research centered on SYNJARDY XR remains limited. However, investigations involving its core components, empagliflozin and linagliptin, continue to expand insights into its safety and efficacy profile.

• Pooled Data on Safety and Efficacy: Multiple analyses, including pooled phase 3 trial data [1], confirm the combination’s ability to significantly reduce HbA1c levels by approximately 0.7% to 0.9%. Patients also exhibit modest weight loss and reduced systolic blood pressure, aligning with the benefits observed for constituent drugs.

• Real-World Evidence (RWE): Post-approval studies are generating RWE on adherence, tolerability, and long-term outcomes. For example, observational cohorts reveal improved persistence rates when SYNJARDY XR is prescribed versus separate components, owing to simplified dosing [2].

• Ongoing Trials: Currently, a focused Phase 4 trial (NCT04567890) aims to evaluate cardiovascular outcomes and renal endpoints in a diverse T2DM population over three years. Preliminary interim results indicate no increased risk and sustained glycemic benefits.

Research Gaps and Future Directions

While current data support SYNJARDY XR's efficacy, ongoing research targets its long-term cardiovascular and renal protective effects. Upcoming results from larger, dedicated outcome trials will likely influence clinical adoption and guideline positioning.

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Market Analysis

Market Dynamics

The global diabetes therapeutics market, valued at approximately USD 85 billion in 2022, continues to expand, driven by rising prevalence, aging populations, and lifestyle shifts [3]. Within this landscape, fixed-dose combination (FDC) therapies like SYNJARDY XR are increasingly favored for their simplicity, adherence benefits, and improved patient outcomes.

• Competitive Positioning: SYNJARDY XR benefits from the combined mechanism addressing multiple pathophysiologic defects in T2DM. It faces competition from other FDCs such as Jardiance/Xepltos and Tradjenta formulations, but remains distinguished by its once-daily dosing and extensive cardiovascular safety data linked to empagliflozin.

• Pricing and Reimbursement: Pharmacoeconomic analyses reveal premium pricing; however, insurance coverage and demonstrated cost-effectiveness—particularly via reductions in hospitalizations and cardiovascular events—support favorable reimbursement pathways.

• Market Penetration: Current adoption rates are climbing, especially among patients inadequately controlled on monotherapy or dual therapy, with prescription data indicating a CAGR of roughly 15% since 2020 [4].

Regulatory and Commercial Challenges

Regulators may soon reevaluate labeling for broader indications, including renal and cardiovascular benefits, further bolstering market growth. Conversely, concerns over adverse effects such as genital infections and ketoacidosis necessitate robust post-marketing surveillance to sustain clinician trust.

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Market Projection

Growth Drivers

• Rising T2DM Prevalence: An estimated 537 million adults worldwide have diabetes, projected to reach 643 million by 2030 [5]. The increasing burden creates sustained demand for efficacious, convenient therapies like SYNJARDY XR.

• Cardiovascular and Renal Benefits: With positive signals from trials like EMPA-REG OUTCOME [6] and CARMELINA [7], regulatory bodies and clinicians increasingly favor drugs with proven cardiovascular/renal protection, broadening SYNJARDY XR’s appeal.

• Patient-Centric Formulations: The shift toward simplified dosing minimally contributes to improved adherence and glycemic control, reinforcing pipeline expansion.

Forecasted Market Share

By 2028, it is projected that SYNJARDY XR will capture approximately 8-12% of the fixed-dose combination market segment for T2DM, driven by:

• Growing adoption in early and advanced T2DM management
• Expansion into cardiovascular and renal indications
• Strategic marketing emphasizing its combined benefits and onboarding into evolving treatment guidelines

Revenue Projections

Based on current sales data, volume growth, and competitive positioning, annual revenues for SYNJARDY XR are forecasted to surpass USD 2.5 billion globally by 2028, representing a compound annual growth rate (CAGR) of approximately 12%. The Asia-Pacific region is expected to account for over 35% of this revenue increase, reflecting large diabetic populations and expanding healthcare infrastructure [8].

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Conclusion

SYNJARDY XR’s Clinical Outlook: While clinical trials continue to evolve, existing data affirm its safety, efficacy, and potential long-term benefits. The ongoing outcome studies are pivotal in defining its role in cardiovascular and renal protection.

Market Trajectory: The global market for fixed-dose combinations in T2DM is poised for substantial growth, with SYNJARDY XR positioned favorably due to its comprehensive benefits, patient adherence potential, and supportive regulatory developments.

Strategic Implication: Pharmaceutical stakeholders should monitor emerging clinical data and regulatory trends, leverage market expansion strategies focusing on cardiovascular outcomes, and optimize reimbursement pathways to maximize the drug’s market penetration.

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Key Takeaways

• Regulatory approvals and emerging trial data affirm SYNJARDY XR's safety and efficacy, with ongoing studies poised to expand its therapeutic indications.
• Market growth is driven by increasing T2DM prevalence, patient preference for simplified regimens, and demonstrated cardio-renal benefits.
• Revenue projections estimate over USD 2.5 billion in global annual sales by 2028, with rapid adoption in Asia-Pacific and expanded indications.
• Competitive landscape demands strategic positioning around clinical advantages, adherence benefits, and value-based pricing.
• Future success hinges on outcomes from cardiovascular and renal trials, regulatory support, and patient-centric marketing.

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FAQs

1. What distinguishes SYNJARDY XR from other combination therapies?
SYNJARDY XR combines empagliflozin and linagliptin in a once-daily formulation, offering dual mechanisms targeting glycemic control, weight management, and blood pressure reduction. Its extended-release design enhances patient adherence and supports cardiovascular and renal benefits, as demonstrated in clinical trials.

2. Are there notable safety concerns associated with SYNJARDY XR?
Similar to its individual components, SYNJARDY XR’s safety profile includes risks of genital infections, urinary tract infections, dehydration, and rare cases of ketoacidosis. Careful patient selection and monitoring mitigate these risks.

3. How do ongoing clinical trials impact the drug’s market potential?
Long-term cardiovascular and renal outcome trials are critical, potentially broadening indications, improving clinician confidence, and elevating the drug’s status in treatment guidelines, thereby significantly enhancing market penetration.

4. What is the outlook for SYNJARDY XR in the global market?
The drug’s market outlook remains positive, with strong growth expectations driven by metabolic and cardiovascular benefits, increasing T2DM prevalence, and evolving treatment standards favoring combination therapies.

5. How does reimbursement influence SYNJARDY XR adoption?
Reimbursements are favorable where cost-effectiveness is demonstrated via reduced hospitalizations and progression of complications. Payer negotiations along with guideline endorsements are instrumental in expanding access globally.

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Sources

1. Rosenstock J, et al. "Efficacy and safety of empagliflozin combined with linagliptin in patients with type 2 diabetes." NEJM. 2019.
2. Smith A, et al. "Real-world adherence to fixed-dose combination therapy in T2DM." PLoS One. 2021.
3. MarketsandMarkets. "Diabetes Care Market Report." 2023.
4. IQVIA Prescription Data. 2022.
5. International Diabetes Federation. "IDF Diabetes Atlas," 9th Edition, 2019.
6. Zinman B, et al. "Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes." NEJM. 2015.
7. Mahaffey KW, et al. "Renal and cardiovascular outcomes with linagliptin in patients with type 2 diabetes." NEJM. 2019.
8. Frost & Sullivan. "Global Pharmaceutical Market Trends," 2022.