All Clinical Trials for synjardy

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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.
NCT06823856 ↗	Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, G	COMPLETED	Gedeon Richter Plc.	PHASE1	2025-05-11	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 12.5 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.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Condition Name for synjardy
Diabetes Mellitus Type 2	3
Healthy	1
Type 2 Diabetes Mellitus (T2DM)	1
Type2diabetes	1
[disabled in preview]	1
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Condition MeSH for synjardy
Diabetes Mellitus, Type 2	4
Diabetes Mellitus	3
[disabled in preview]	1
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Trials by Country for synjardy
Russia	3
Egypt	1
India	1
Jordan	1
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Clinical Trial Phase for synjardy
PHASE1	5
Phase 1	1
[disabled in preview]	0
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Clinical Trial Status for synjardy
Completed	6
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Sponsor Name for synjardy
Gedeon Richter Plc.	3
Hikma Pharma	1
Genuine Research Center, Egypt	1
[disabled in preview]	2
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Sponsor Type for synjardy
Industry	6
Other	1
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Last updated: May 3, 2026

SYNJARDY Clinical Trials Update, Market Analysis, and Projection

What is SYNJARDY and what claims does it support?

SYNJARDY is an oral fixed-dose combination product for Type 2 diabetes that contains empagliflozin (SGLT2 inhibitor) + metformin (immediate-release or extended-release metformin depending on the product strength). It is marketed for glycemic control in adults with Type 2 diabetes, including use in patients already treated with individual components.

Product naming context (commercial):

SYNJARDY: empagliflozin + metformin (fixed-dose combinations)
SYNJARDY XR: empagliflozin + metformin extended-release (fixed-dose combinations)

Mechanism-of-action pairing (clinical rationale):

Empagliflozin reduces renal glucose reabsorption (SGLT2 inhibition).
Metformin reduces hepatic glucose production and improves insulin sensitivity.

Regulatory footprint (U.S.): SYNJARDY is an FDA-approved combination product; the product is referenced in the FDA label for dosing, indications, contraindications, warnings, and clinical pharmacology. (Source: FDA labeling for SYNJARDY and SYNJARDY XR: [1], [2])

Which clinical trial programs drive SYNJARDY’s evidence base?

SYNJARDY does not run one single dedicated Phase 3 program across every indication listed on-label. Instead, its evidence base is built from:

Empagliflozin clinical outcomes program evidence (notably cardiovascular and renal endpoints),
Metformin clinical history,
Bioequivalence and PK/clinical bridging work for the fixed-dose combinations (to support interchangeable dosing with co-administered components),
Label-specific efficacy data and comparative control logic from combination-relevant studies.

Cardiovascular and renal outcomes: empagliflozin foundation

Key outcomes evidence for empagliflozin informs the clinical positioning used across SGLT2 inhibitor class and the combination’s label claims.

EMPA-REG OUTCOME: empagliflozin in Type 2 diabetes with established cardiovascular disease reduced risk for cardiovascular death and all-cause mortality, and improved heart failure outcomes. (Source: NEJM publication: [3])
Empagliflozin in kidney disease and renal outcomes has been supported by programmatic trials such as EMPA-KIDNEY (renal benefits in broad chronic kidney disease populations, including Type 2 diabetes subsets). (Source: NEJM publication: [4])

These outcomes programs are the primary clinical evidence backbone that investors and payers use to underwrite value beyond A1c lowering.

Fixed-dose combination support for SYNJARDY

For combination products like SYNJARDY, regulators require evidence that exposure from the fixed-dose combination is comparable to the individual components administered separately (bioequivalence), and that safety signals align.

FDA labeling for SYNJARDY and SYNJARDY XR consolidates clinical pharmacology and clinical studies supporting the combination’s dosing and tolerability. (Source: FDA labels: [1], [2])

What is the current clinical trial “update” status for SYNJARDY as a product?

A practical clinical-trials update for SYNJARDY hinges on two layers:

Empagliflozin ongoing trials that can extend or refine indications and outcomes within SGLT2 inhibitor use cases.
Combination-specific changes (new strengths, populations, label expansions) that are typically supported by bridging and protocol-adjacent data.

As of the most recent public trial registry view, SYNJARDY’s clinical activity is generally expressed through:

Continuation and subgroup analyses in empagliflozin outcomes lines,
Ongoing renal and cardiovascular post-approval studies in related populations,
Potential label refinements around renal function, dosing limits, and cardiovascular-risk subgroups.

Because SYNJARDY is a fixed-dose combination, it is not typically the direct sponsor name for every outcomes protocol; evidence is usually attributed to the empagliflozin component while combination labeling reflects those results and ensures dosing alignment through combination PK/clinical studies. (Source: FDA label sections and class outcomes anchoring: [1], [2], [3], [4])

How big is SYNJARDY’s market, and what segments should investors watch?

Where does SYNJARDY monetize most effectively?

SYNJARDY targets Type 2 diabetes patients who need both:

glucose lowering (metformin base),
additional cardiometabolic benefit (empagliflozin).

The highest-value commercialization vectors:

Patients inadequately controlled on metformin (or metformin plus lifestyle).
Patients with higher cardiovascular and renal risk where SGLT2 inhibitors drive durable outcomes.
Adherence improvement by reducing pill burden vs co-administering two agents separately.

Market context: class dynamics

The SGLT2 inhibitor market is mature but still expanding through:

renal indication expansion,
earlier-line adoption as guidelines evolve,
fixed-dose combinations gaining share due to payer and adherence incentives.

SYNJARDY competes in the oral T2D combination landscape against other SGLT2/metformin fixed-dose combos and broader add-on regimens.

Competitor grouping (fixed-dose SGLT2/metformin):

Dapagliflozin/metformin combinations
Canagliflozin/metformin combinations
Other empagliflozin/metformin fixed-dose variants (depending on geography and specific brand formulations)

Pricing and reimbursement: what matters

For market projection, the highest sensitivity variables for SYNJARDY are:

Net price after rebates in Medicare and commercial lines,
Formulary placement vs competing SGLT2 combinations,
Prior authorization criteria tied to A1c, prior metformin exposure, or cardiovascular/renal criteria.

What is the projection outlook for SYNJARDY through the next 3 to 7 years?

Base case demand driver model

Projection should be anchored to three compounding effects:

SGLT2 outcomes adoption
- Continued uptake in cardiorenal-risk cohorts.
- Growth in kidney disease treated populations.
Fixed-dose combination substitution
- Ongoing switch from separate dosing to fixed-dose for adherence and simplification.
Indication shelf-life
- Outcomes evidence for empagliflozin supports expanding clinical use, assuming label and payer alignment continue.

Key constraints that cap growth

Patent and exclusivity periods
- Combination brands face generic pressure once relevant protections expire (component-level and formulation-level protections).
SGLT2 class competition
- Competitors with aggressive contracting and broader guideline penetration can cap share.
Safety and tolerability filters
- Expected class-wide issues (e.g., genital mycotic infections, volume depletion, rare ketoacidosis) can affect persistence and prescriber behavior.

Actionable projection frame (investor use)

Given the mature nature of SGLT2 inhibitors and the combination’s reliance on component outcomes, the projection is most credible when treated as a share-and-net-price exercise rather than a pure volume growth story.

Projection should track:

net price trajectory (rebate intensity and tender outcomes),
formulary share among oral combination regimens,
persistence (dose continuity after early tolerability period),
conversion rate from metformin monotherapy or add-on SGLT2 uptake into fixed-dose.

Evidence, labeling, and safety positions that affect utilization

What label warnings and dosing rules drive clinician behavior?

SYNJARDY and SYNJARDY XR contain standard SGLT2 and metformin safety labeling, including:

risk management around renal function thresholds,
risk mitigation for lactic acidosis (metformin),
volume depletion precautions (SGLT2),
ketoacidosis warning language (SGLT2).

These sections influence real-world discontinuation and switching behavior, which is central to persistence assumptions in market models. (Source: FDA labels: [1], [2])

Key Takeaways

SYNJARDY is a fixed-dose combination of empagliflozin + metformin, with clinical value anchored by empagliflozin cardiorenal outcomes and combination-specific dosing support in FDA labeling. (Sources: [1], [2], [3], [4])
Market performance is dominated by SGLT2 adoption in cardiorenal-risk patients, plus fixed-dose substitution for adherence and simplifying regimens.
Forward projections should be built as share and net-price driven, with persistence and payer contracting as core sensitivities.
Utilization will remain constrained by generic pressure timelines and class competition, while label safety language shapes early persistence and switching.

FAQs

1) Does SYNJARDY have separate outcomes trials proving CV and renal benefit?

The outcomes foundation is primarily the empagliflozin outcomes program (e.g., EMPA-REG OUTCOME for cardiovascular and EMPA-KIDNEY for renal), while the fixed-dose combination is supported via combination dosing, PK, and labeling evidence. (Sources: [3], [4], [1], [2])

2) What differentiates SYNJARDY from using empagliflozin and metformin separately?

SYNJARDY is a fixed-dose regimen that can improve adherence and simplifies prescribing and dosing logistics versus co-administering the components separately. Labeling supports dosing and pharmacology for fixed-dose use. (Sources: [1], [2])

3) What patient profiles should drive the highest SYNJARDY demand growth?

Patients with Type 2 diabetes at elevated cardiovascular and/or renal risk where SGLT2 inhibitors are prioritized, plus patients inadequately controlled on metformin who can be moved to an oral combination. (Sources: [3], [4], [1])

4) What are the biggest bottlenecks to SYNJARDY growth?

Net price compression from contracting pressure, formulary competition within SGLT2-metformin combinations, and future generic entry timing that can materially change share and pricing. (Sources: [1], [2])

5) Which label sections are most likely to affect persistence and switching?

Safety and dosing sections tied to renal function, volume status, risk of lactic acidosis (metformin), and ketoacidosis risk mitigation (SGLT2). (Sources: [1], [2])

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). SYNJARDY (empagliflozin and metformin hydrochloride) prescribing information.
[2] U.S. Food and Drug Administration. (n.d.). SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release) prescribing information.
[3] Zinman, B., Wanner, C., Lachin, J. M., et al. (2015). Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. New England Journal of Medicine.
[4] The EMPA-KIDNEY Collaborative Group. (2022). Empagliflozin in patients with chronic kidney disease. New England Journal of Medicine.

CLINICAL TRIALS PROFILE FOR SYNJARDY