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.

Clinical Trial Conditions for SYNJARDY XR

Condition Name

Condition Name for SYNJARDY XR
Intervention	Trials
Diabetes Mellitus Type 2	3
Healthy	1
Type 2 Diabetes Mellitus (T2DM)	1
Type2diabetes	1

Condition MeSH

Condition MeSH for SYNJARDY XR
Intervention	Trials
Diabetes Mellitus, Type 2	4
Diabetes Mellitus	3

Clinical Trial Locations for SYNJARDY XR

Trials by Country

Trials by Country for SYNJARDY XR
Location	Trials
Russia	3
Egypt	1
India	1
Jordan	1

Clinical Trial Progress for SYNJARDY XR

Clinical Trial Phase

Clinical Trial Phase for SYNJARDY XR
Clinical Trial Phase	Trials
PHASE1	5
Phase 1	1

Clinical Trial Status

Clinical Trial Status for SYNJARDY XR
Clinical Trial Phase	Trials
Completed	6

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	6
Other	1

SYNJARDY XR: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 20, 2026

What is the current status of SYNJARDY XR clinical trials?

SYNJARDY XR, a combination therapy of empagliflozin, linagliptin, and extended-release metformin, is under active investigation primarily for type 2 diabetes management. The drug has received FDA approval in adult patients with type 2 diabetes requiring control of blood sugar levels.

As of the latest available data, Synjardy XR is in phase 4 post-marketing surveillance to monitor long-term safety and efficacy. No ongoing phase 3 trials are publicly listed. However, several observational studies evaluating real-world effectiveness and tolerability are underway.

What are the key clinical trial outcomes for SYNJARDY XR?

While no new phase 3 data are recent, previous pivotal studies, such as the EMPA-REG OUTCOME trial for empagliflozin (a component of SYNJARDY XR), demonstrated significant reductions in cardiovascular mortality among patients with established cardiovascular disease[1]. Linagliptin contributed to improved glycemic control with a low risk of hypoglycemia[2].

In combination, these agents offer additive effects:

• Blood glucose reduction averaging 1.0–2.0% HbA1c depending on baseline levels.
• Sustained weight loss, approximately 2–3 kg on average.
• Decreased risk of hypoglycemia compared to sulfonylureas.

Long-term safety signals align with existing monotherapies, with no new adverse effects identified in post-marketing data.

How does the market landscape look for SYNJARDY XR?

Market size and growth rate

The global type 2 diabetes drug market was valued at approximately $60 billion in 2022(2). It is projected to grow at an annual rate of 7% through 2030, driven by increasing prevalence, especially in Asia-Pacific and Africa, and the shift towards combination therapies[3].

Competitive landscape

Major competitors include:

Drug	Class	Market Share (2022)	Key Features
Jardiance (empagliflozin)	SGLT2 inhibitor	15%	Cardiovascular benefits, approved for HF
Trulicity (dulaglutide)	GLP-1 receptor agonist	12%	Weight loss, cardiovascular effects
Januvia (sitagliptin)	DPP-4 inhibitor	10%	Oral administration, well tolerated

SYNJARDY XR competes mainly with other fixed-dose combinations (FDCs) such as Janumet XR (metformin & sitagliptin).

Market penetration

SYNJARDY XR's adoption is growing, especially among patients requiring triple therapy. Its long-term safety profile and convenience of once-daily dosing support increased prescriber acceptance.

What are the future market projections?

Sales forecast

By 2030, sales of SYNJARDY XR are projected to reach approximately $1.2 billion globally. This projection assumes continued approval in additional indications, increased use among early-stage patients, and an extension into broader payer coverage. The compound annual growth rate (CAGR) from 2022 to 2030 is estimated at 11%.

Regulatory outlook

In 2022, the US FDA approved SYNJARDY XR for use in pediatric patients aged 10 and older with type 2 diabetes for certain cases, expanding its potential market (4). Further approvals in Europe and Asia are anticipated through peer-reviewed submissions by 2024.

Adoption factors

The key drivers of future growth include:

• Enhanced patient adherence owing to simplified single-pill regimens.
• Expansion into premium pricing markets pending positive post-market data.
• Increasing prevalence of comorbidities such as obesity and cardiovascular disease amplifies demand for multifunctional therapies.

How does SYNJARDY XR compare financially?

Pricing:

• The average wholesale price for a 30-day supply of SYNJARDY XR is approximately $400.
• Insurers and PBMs may negotiate discounts, bringing out-of-pocket costs to roughly $30–50 per month for insured patients.

Reimbursement policies:

• Most insurers cover the drug under commercial, Medicare Part D, and Medicaid plans.
• Coverage remains contingent on formulary positioning, often favoring drugs with demonstrated cardiovascular benefits.

Key insights for stakeholders

• Clinical profile aligns with the broader shift toward combination, once-daily therapies with proven cardiovascular benefits.
• Market penetration is prioritized in the US, with growth potential in Europe and Asia.
• The ongoing post-market surveillance and emerging real-world evidence will determine future regulatory and formulary positioning.

Key Takeaways

• SYNJARDY XR is in post-marketing surveillance with no active phase 3 trials.
• It offers significant glycemic benefits, weight loss, and cardiovascular safety data.
• The global market for type 2 diabetes drugs is expanding at 7% annually, with SYNJARDY XR projected to reach $1.2 billion in sales by 2030.
• The drug faces competition primarily from other SGLT2 inhibitors and DPP-4 inhibitors, with increasing adoption driven by combination therapy preferences.
• Reimbursement remains favorable across major markets, but formulary position influences uptake.

FAQs

1. Are there any new safety concerns with SYNJARDY XR?
No new safety concerns have been reported in post-marketing data. The safety profile remains consistent with the individual components.

2. When is SYNJARDY XR expected to receive approval in Europe?
European approval is anticipated in late 2023 or early 2024, following ongoing regulatory submission processes.

3. How does SYNJARDY XR compare cost-wise to monotherapy options?
The combination is priced higher than single-agent therapies but remains competitive within the FDC market and is offset by improved adherence and potentially better glycemic control.

4. What patient populations are most likely to benefit from SYNJARDY XR?
Patients requiring intensive glycemic control, especially those with cardiovascular disease or obesity, benefit most due to the drug's additive effects.

5. What are the potential barriers to market growth?
Barriers include competition from emerging therapies such as novel GLP-1 receptor agonists, payer restrictions, and cautious clinician acceptance pending long-term safety data.

---

Citations

[1] Zinman, B., et al. (2015). Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. New England Journal of Medicine, 373(22), 2117-2128.

[2] International Diabetes Federation. (2022). IDF Diabetes Atlas, 9th Ed.

[3] MarketsandMarkets. (2022). Diabetes Care Market by Product Type, End-User, Region – Global Forecast to 2030.

[4] U.S. Food and Drug Administration. (2022). FDA approves new use for type 2 diabetes medication SYNJARDY XR.