CLINICAL TRIALS PROFILE FOR JARDIANCE

505(b)(2) Clinical Trials for JARDIANCE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT06083675 ↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

All Clinical Trials for JARDIANCE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01001962 ↗	Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics	Unknown status	Aristotle University Of Thessaloniki	Phase 4	2016-01-01	Objectives: Primary 1. Primary prevention of new onset of hypertension Secondary 1. Reduction of 24h BP in type II diabetics with prehypertension 2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN 3. Reduction in the total cardiovascular risk 4. 3 years morbidity and mortality rates 5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN
NCT02367131 ↗	Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus	Completed	Eli Lilly and Company		2015-02-24	Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
NCT02367131 ↗	Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus	Completed	Boehringer Ingelheim		2015-02-24	Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
NCT02401880 ↗	Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 4	2015-05-01	The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients. This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.
NCT02471963 ↗	Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function	Completed	University of Erlangen-Nürnberg Medical School	Phase 3	2014-12-01	Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and obesity.
NCT02489942 ↗	Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus	Completed	Eli Lilly and Company		2015-06-12	Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus

Clinical Trial Conditions for JARDIANCE

Condition Name

Condition Name for JARDIANCE
Intervention	Trials
Diabetes Mellitus, Type 2	10
Type 2 Diabetes	6
Type 2 Diabetes Mellitus	6
Heart Failure	5

Condition MeSH

Condition MeSH for JARDIANCE
Intervention	Trials
Diabetes Mellitus	33
Diabetes Mellitus, Type 2	32
Heart Failure	8
Kidney Diseases	8

Clinical Trial Locations for JARDIANCE

Trials by Country

Trials by Country for JARDIANCE
Location	Trials
United States	25
India	16
Poland	10
Germany	9
Austria	8

Trials by US State

Trials by US State for JARDIANCE
Location	Trials
Texas	4
New York	3
Minnesota	3
Ohio	2
Kentucky	1

Clinical Trial Progress for JARDIANCE

Clinical Trial Phase

Clinical Trial Phase for JARDIANCE
Clinical Trial Phase	Trials
PHASE4	4
PHASE1	3
Phase 4	27

Clinical Trial Status

Clinical Trial Status for JARDIANCE
Clinical Trial Phase	Trials
Completed	29
Recruiting	16
Not yet recruiting	15

Clinical Trial Sponsors for JARDIANCE

Sponsor Name

Sponsor Name for JARDIANCE
Sponsor	Trials
Boehringer Ingelheim	17
Eli Lilly and Company	4
Medical University of Vienna	3

Sponsor Type

Sponsor Type for JARDIANCE
Sponsor	Trials
Other	121
Industry	32
NIH	3

Jardiance (empagliflozin): Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is Jardiance’s current clinical position (label-aligned outcomes, trial readouts, and pipeline pressure)?

Jardiance (empagliflozin) is an established SGLT2 inhibitor with broad cardiovascular (CV) and renal positioning. Recent development activity in the category is concentrated in incremental outcomes (new subgroups), earlier disease stages, and combinations (including GLP-1 and triple therapy concepts), rather than replacing the core CV-renal benefit package proven in landmark programs.

Core clinical evidence that still anchors market expectations

Key pillars supporting ongoing demand for Jardiance remain:

• Heart failure across reduced and preserved ejection fraction: mortality and hospitalization benefits established in large outcome trials, extending into HFpEF and broader HF labels.
• Chronic kidney disease: renal composite outcomes (slowing progression and reducing renal events) established in CV-renal outcomes trials using SGLT2 inhibitor class effects.
• Type 2 diabetes (T2D): glycemic efficacy plus weight loss and low hypoglycemia risk profile supports sustained base demand, with expanding use guided by CV and renal risk stratification.

Where trials are tightening the competitive set

While SGLT2 inhibitors share class effects, clinical trial design is moving toward:

• Earlier intervention (lower baseline risk) with event-based endpoints.
• Broader stratification using biomarkers and renal function bands.
• Combination regimens with GLP-1 receptor agonists and newer cardiometabolic agents to address residual risk.

Trial update focus (what investors watch)

For Jardiance specifically, market-moving clinical updates typically come from:

• New subgroup readouts (age, baseline eGFR, albuminuria strata).
• Expansion into additional HF and CKD phenotype definitions.
• Longer follow-up converting surrogate reductions into stronger absolute event separation.

No single new global “replacement” trial readout is required to sustain demand; the market is sustained by label scope durability and iterative evidence that protects differentiation versus other SGLT2 competitors.

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How does Jardiance perform in the market today (share drivers, pricing, and channel dynamics)?

Jardiance’s market performance is driven by the intersection of three demand engines:

1. Persistent label leadership in CV-renal care pathways where SGLT2 inhibitors are embedded into guideline-based prescribing.
2. T2D base that remains large and resilient, especially in patients with obesity and cardiometabolic comorbidity.
3. Competition by “class saturation” that shifts prescribing to risk-based treatment protocols rather than glycemic endpoints alone.

Primary demand drivers

• Guideline-aligned uptake in HF and CKD: clinicians increasingly choose SGLT2 inhibitors for CV and renal risk reduction even when glycemic targets are already managed.
• Low hypoglycemia risk and tolerability: supports primary care and cardiology adoption.
• Combination narratives: pairing with GLP-1 RA and other cardiometabolic strategies supports account growth in specialty-managed T2D and obesity populations.

Key competitive pressure (what changes net pricing and share)

• Peer SGLT2 inhibitors compete across the same endpoints: differentiation increasingly depends on access, formulary position, and payer management rather than efficacy alone.
• Formulary dynamics: payer step therapy and preferred class listing influence switching costs and volume capture.
• Generic and internal share reallocation (class and portfolio effects): as the category matures, brand share is defended through outcomes messaging, real-world evidence, and payer contracting.

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Where is growth most likely (segment, geography, and prescribing setting)?

Jardiance’s most actionable growth paths are segment-based, not just geography-based.

Likely growth segments

• Heart failure patients in cardiology and HF clinics where treatment algorithms are standardized.
• CKD with albuminuria and reduced eGFR bands where SGLT2 inhibitor use becomes a standing risk-reduction step.
• T2D patients with established CV disease or high CV risk, where outcomes-based prescribing persists even as additional antidiabetic agents enter the market.

Prescribing setting shifts

• Specialty-led initiation, primary care continuation: HF and nephrology initiation increases persistence once started.
• Real-world protocolization: more systems embed “SGLT2-first” order sets in EHR pathways.

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What market projections are credible for Jardiance (base case drivers and downside risks)?

A credible projection framework for Jardiance must account for:

• Category growth (SGLT2 adoption expands with guideline uptake).
• Share dynamics inside the class (formulary contracting and peer launches).
• Patent and brand defense economics (brand value versus competitive pricing).
• Clinical differentiation durability (outcomes reaffirmation and subgroup expansions).

Base case projection logic (directional)

• Volume growth remains linked to ongoing expansion of HF and CKD prescribing and continued T2D integration.
• Revenue growth depends on net price erosion risk from competitive contracting, partially offset by higher total addressable patient numbers.
• Market share stability is most likely in accounts where payer policies already favor the SGLT2 class; share then shifts with preferred listing and patient switching patterns.

Key downside risks

• Faster-than-expected price compression from payer formulary moves and deeper contracting by competitors.
• Utilization saturation in the highest-likelihood subpopulations, requiring earlier-stage expansion to sustain growth.
• Safety signal management costs if adverse events monitoring leads to switching or temporary discontinuation patterns in real-world settings.

Key upside risks

• Additional label expansions in HF/CKD phenotypes or earlier disease stages.
• Stronger-than-expected adherence and persistence from protocolized care pathways.
• Combination uptake that reinforces SGLT2 inclusion in multi-drug cardiometabolic regimens.

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Competitive landscape: how does Jardiance stack up inside SGLT2 and beyond?

Jardiance competes in a crowded SGLT2 inhibitor class that also intersects with GLP-1 RA ecosystems for cardiometabolic risk management. Competitive advantage increasingly comes from:

• Formulary status and contracting terms
• Clinical confidence and prescriber behavior
• Real-world persistence and switching patterns

How competition affects projections

• Class maturity typically limits explosive share gains.
• Brand value defense relies on “outcomes-first” prescribing and payer-specific preferred positioning.

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Key takeaways

• Jardiance’s market outlook is anchored by durable CV-renal outcomes and guideline-driven use in HF and CKD, with T2D remaining a stable base.
• Clinical trial strategy across the category is shifting toward earlier intervention, subgroup refinement, and combination regimens, which tends to protect utilization rather than reset the value proposition.
• Growth is most likely to continue through HF and CKD segments and through T2D patients at CV risk, while revenue depends on net price stability amid formulary pressure.
• The projection hinge points are payer contracting (price compression), utilization saturation risk, and whether label-aligned expansions extend earlier-stage uptake.

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FAQs

1) Does Jardiance’s growth depend more on heart failure or diabetes?

HF and CKD drive disproportionate incremental prescribing because SGLT2 inhibitors are embedded in cardiology and nephrology risk-reduction pathways. Diabetes remains the volume base, but HF/CKD typically drive higher persistence and clinical-program adoption.

2) What is the biggest market risk for Jardiance?

Net price erosion from formulary contracting and preferred-list switching within the SGLT2 class.

3) How do clinical trial readouts typically affect Jardiance?

They most often reinforce or expand label-aligned usage in HF and CKD subgroups rather than overturning existing prescribing patterns.

4) Will combinations (SGLT2 plus GLP-1) dilute Jardiance?

They can extend addressable patient segments by targeting residual cardiometabolic risk, but they also increase competitive intensity and may shift how payers allocate preferred therapy.

5) What would most strengthen Jardiance’s projection upside?

New approvals that broaden earlier-stage HF or CKD populations into routine prescribing algorithms, combined with strong persistence in real-world care pathways.

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References

[1] FDA. Drug Approval Package: Jardiance (empagliflozin).
[2] EMA. Jardiance (empagliflozin): EPAR product information.
[3] New England Journal of Medicine. Landmark CV outcomes and HF/CKD trials of empagliflozin (and related SGLT2 outcome evidence).
[4] American Diabetes Association. Standards of Care in Diabetes (latest annual edition).
[5] American College of Cardiology/American Heart Association. Guideline recommendations for heart failure and SGLT2 inhibitor use (latest annual updates).