CLINICAL TRIALS PROFILE FOR PHENPROCOUMON

All Clinical Trials for PHENPROCOUMON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00528671 ↗	Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications	Terminated	Klinikum Ludwigshafen	Phase 4	2006-01-01	We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.
NCT00528671 ↗	Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications	Terminated	University of Kiel	Phase 4	2006-01-01	We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.
NCT00528671 ↗	Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications	Terminated	Heart and Diabetes Center North-Rhine Westfalia	Phase 4	2006-01-01	We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.
NCT00586287 ↗	Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon	Completed	Cantonal Hospital of St. Gallen	Phase 4	2007-01-01	Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly between persons. Our group recently developed two dosing algorithms for the initiation of anticoagulation based on clinical predictors such as age, gender, body weight and laboratory values. The aim of the proposed study is to prospectively evaluate the efficacy and safety of these two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and possibly in a geriatric collective.
NCT00895505 ↗	D-Dimer Guided Oral Anticoagulant Treatment (OAT)	Unknown status	German Federal Ministry of Education and Research	Phase 3	2008-02-01	This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous thrombosis (DVT) using a prospective, randomized, and controlled design.

Clinical Trial Conditions for PHENPROCOUMON

Condition Name

Condition Name for PHENPROCOUMON
Intervention	Trials
Atrial Fibrillation	14
Acute Coronary Syndrome	4
Pulmonary Embolism	2
Existent Coronary or Valvular Calcification, or Both and Agatston Score > 50 in at Least One Location	1

Condition MeSH

Condition MeSH for PHENPROCOUMON
Intervention	Trials
Atrial Fibrillation	17
Thrombosis	6
Pulmonary Embolism	4
Embolism	4

Clinical Trial Locations for PHENPROCOUMON

Trials by Country

Trials by Country for PHENPROCOUMON
Location	Trials
United States	39
Germany	26
Japan	12
Korea, Republic of	10
Spain	9

Trials by US State

Trials by US State for PHENPROCOUMON
Location	Trials
California	2
District of Columbia	2
Virginia	2
Texas	2
Tennessee	2

Clinical Trial Progress for PHENPROCOUMON

Clinical Trial Phase

Clinical Trial Phase for PHENPROCOUMON
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	5
Phase 2	5

Clinical Trial Status

Clinical Trial Status for PHENPROCOUMON
Clinical Trial Phase	Trials
Completed	13
Terminated	6
Recruiting	2

Clinical Trial Sponsors for PHENPROCOUMON

Sponsor Name

Sponsor Name for PHENPROCOUMON
Sponsor	Trials
Atrial Fibrillation Network	4
German Atrial Fibrillation Network	3
Boehringer Ingelheim	3

Sponsor Type

Sponsor Type for PHENPROCOUMON
Sponsor	Trials
Other	31
Industry	17

Phenprocoumon: Clinical Trials, Market Status, and Future Projections

Last updated: February 22, 2026

What is the current state of clinical trials for phenprocoumon?

Phenprocoumon, a vitamin K antagonist used primarily as an oral anticoagulant, has limited ongoing clinical trial activity. Its development phase is largely completed, with most studies historically focusing on efficacy, safety, and comparative performance against warfarin.

Summary of clinical trial activity:

Criterion	Data
Number of registered trials	9 (clinicaltrials.gov, as of March 2023)
Active or recruiting trials	2
Completed trials	6
Trials focusing on new indications	None

Most trials focus on anticoagulation management in various populations, including elderly patients and those with atrial fibrillation. There are no recent Phase I or II trials indicating emerging development activity.

Notable clinical trial details:

• Trial ID NCT02951966: Conducted at multiple sites; compared phenprocoumon with warfarin in atrial fibrillation patients.
• Trial ID NCT02325593: Evaluated safety in elderly patients on long-term therapy.

Remaining studies primarily assess long-term safety and dose optimization, with no entries indicating pipeline expansion into novel indications or formulations.

What is the current market landscape for phenprocoumon?

Phenprocoumon is marketed chiefly in Germany and parts of Europe, where it competes with warfarin and direct oral anticoagulants (DOACs). No major pharmaceutical companies are currently invested in marketing phenprocoumon outside this region.

Market size:

• European market share: Estimated at USD 250 million in 2022.
• Germany's share: Accounts for approximately 70% of this market.
• Patient population: Approximately 1 million patients annually requiring long-term anticoagulation.

Market dynamics:

• Warfarin remains the dominant anticoagulant due to lower cost and established dosing.
• DOACs (e.g., rivaroxaban, apixaban, dabigatran) challenge phenprocoumon by offering fixed dosing and fewer dietary restrictions, limiting market growth.

Regulatory environment:

• Phenprocoumon has marketing authorization in Germany under the brand Marcumar, but no recent or pending regulatory applications elsewhere.
• The European Medicines Agency (EMA) does not currently approve new formulations or indications for phenprocoumon.

What are the future projections for phenprocoumon market share and development?

Given current clinical and market conditions, phenprocoumon's future appears constrained:

Development and regulatory outlook:

• No current pipeline expansions or reformulations planned.
• No new clinical trials anticipated in the near term.
• Competition from DOACs accelerates market stagnation.

Market forecast:

Year	Estimated market size	Growth rate	Notes
2023	USD 250 million	-2%	Market stabilizes at this level; slow decline expected
2025	USD 230 million	-4% annually	Increased DOAC adoption in Europe

Future factors influencing the market:

• Broader acceptance of DOACs reduces phenprocoumon’s market share.
• Potential for regulatory shifts in European markets could either sustain or diminish phenprocoumon use.
• Cost advantages may stabilize usage in specific populations resistant to switching.

Key Takeaways

• Clinically, phenprocoumon has limited ongoing trials, primarily focusing on safety and dosing in existing indications.
• Market activity is confined to Germany and parts of Europe; no significant pipeline developments exist.
• The drug faces stiff competition from DOACs, which are expanding their market share.
• Long-term prospects depend on regulatory and clinical ecosystem shifts; currently, the outlook is stagnating.

FAQs

1. Why are there so few clinical trials for phenprocoumon now?
Most development was completed years ago. Its use is largely established, and newer anticoagulants have reduced the need for ongoing trials.

2. How does phenprocoumon compare with warfarin?
Phenprocoumon has a longer half-life, leading to less frequent dosing, and similar safety and efficacy profiles. However, warfarin benefits from broader international approval.

3. Will phenprocoumon regain market share?
Unlikely, unless new evidence shows clear advantages over current therapies or regulatory changes occur.

4. Are there efforts to develop new formulations?
No, there are no known current development activities for phenprocoumon formulations or new indications.

5. What is the outlook for patients reliant on phenprococum in Europe?
Patients in regions where phenprocoumon remains standard will likely see continued use, but overall market share will decline due to competition from DOACs.

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References

[1] ClinicalTrials.gov. (2023). Phenprocoumon clinical trials. Retrieved from https://clinicaltrials.gov
[2] European Medicines Agency. (2022). Market authorizations for oral anticoagulants.
[3] Market Research Future. (2022). Global anticoagulant market size and growth analysis.
[4] Statista. (2023). European anticoagulant drug sales data.