CLINICAL TRIALS PROFILE FOR BECAPLERMIN

All Clinical Trials for becaplermin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00034788 ↗	A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX	Terminated	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2000-12-01	The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
NCT00389636 ↗	TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers	Unknown status	Solsys Medical LLC	N/A	2006-09-01	Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.
NCT00389636 ↗	TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers	Unknown status	Soluble Systems, LLC	N/A	2006-09-01	Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.
NCT00446472 ↗	Evaluation of Windowed Casts With and Without Regranex® Gel for Healing Diabetic Neuropathic Ulcers	Unknown status	Heritage Medical Research Institute	N/A	2007-04-01	The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.
NCT00446472 ↗	Evaluation of Windowed Casts With and Without Regranex® Gel for Healing Diabetic Neuropathic Ulcers	Unknown status	Southern California Institute for Research and Education	N/A	2007-04-01	The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.

Clinical Trial Conditions for becaplermin

Condition Name

Condition Name for becaplermin
Intervention	Trials
Diabetic Foot	3
Diabetes Mellitus	2
Diabetic Foot Ulcers	2
Diabetic Neuropathies	2

Condition MeSH

Condition MeSH for becaplermin
Intervention	Trials
Diabetic Foot	6
Foot Ulcer	5
Ulcer	4
Diabetes Mellitus	2

Clinical Trial Locations for becaplermin

Trials by Country

Trials by Country for becaplermin
Location	Trials
India	6
United States	2
France	1

Trials by US State

Trials by US State for becaplermin
Location	Trials
California	1
Illinois	1

Clinical Trial Progress for becaplermin

Clinical Trial Phase

Clinical Trial Phase for becaplermin
Clinical Trial Phase	Trials
Phase 3	2
Phase 1/Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for becaplermin
Clinical Trial Phase	Trials
Completed	5
Unknown status	2
Terminated	1

Clinical Trial Sponsors for becaplermin

Sponsor Name

Sponsor Name for becaplermin
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	3
Solsys Medical LLC	1
Soluble Systems, LLC	1

Sponsor Type

Sponsor Type for becaplermin
Sponsor	Trials
Industry	8
Other	4

Becaplermin Market Analysis and Financial Projection

Last updated: February 6, 2026

What is the current status of clinical trials for Becaplermin?

Becaplermin (marketed as Regranex) is a recombinant human platelet-derived growth factor (PDGF-BB) used primarily for diabetic foot ulcers. The drug received FDA approval in 1997 for this indication. It has not undergone recent large-scale Phase III clinical trials. Most clinical research up to 2021 focused on post-market safety monitoring and comparative effectiveness studies, rather than new indications or formulations.

Recent Clinical Trials Data:

• According to ClinicalTrials.gov, the last updates on Becaplermin involved observational or safety studies, rather than large randomized trials.

• No ongoing or planned Phase III or IV trials for new indications or expanded uses as of December 2022.

• Fewer than 10 active or completed studies related to Becaplermin since 2018, primarily focusing on wound healing outcomes in specific patient populations.

Implication: The drug's development pipeline appears static, with clinical interest mainly in its established indication.

What is the market landscape for Becaplermin?

The market for Becaplermin has contracted over the past decade due to several factors:

• Limited approval for new indications restricts growth opportunities.

• The emergence of alternative treatments, such as advanced wound dressings, growth factors, and skin substitutes.

• Concerns over safety, including potential malignancy risk associated with growth factor therapies, have tempered enthusiasm.

Market size (2021):

Metric	Value	Source
Global diabetic foot ulcer treatment market	Approximately $4 billion	MarketsandMarkets[1]
Becaplermin's market share	Estimated below 10%	Industry analysis, IQVIA[2]
Revenue in 2021	Estimated around $150 million	IQVIA, company reports

Regional distribution:

• North America dominates due to early approval and established clinical use.

• Europe accounts for a significant share with approvals in multiple countries.

• Market penetration in emerging markets remains limited.

How is the market projected to evolve?

Growth prospects for Becaplermin are limited without new clinical data or expanded indications. The following factors influence the outlook:

• Competitive landscape: Alternative therapies like tissue engineered skin substitutes and biologic dressings continue to evolve, often offering comparable or superior efficacy with fewer safety concerns.

• Regulatory environment: Stricter safety monitoring and potential label restrictions limit aggressive promotion.

• Pricing and reimbursement: High treatment costs and reimbursement challenges restrict adoption.

Projection (2022–2027):

Parameter	Forecast	Source
Compound annual growth rate (CAGR)	1-2%	Frost & Sullivan[3]
Market size by 2027	Around $4.2 billion	Industry analyst estimates
Becaplermin's sales volume	Marginal growth expected	Industry sources

Key drivers:

• Increasing incidence of diabetic foot ulcers, especially in aging populations.

• Incremental adoption in developing countries adopting advanced wound care.

Key risks:

• Potential safety alerts or regulatory restrictions.

• Competition from bioengineered products and newer growth factor therapies.

What are the key challenges facing Becaplermin?

• Safety concerns stem from post-market reports suggesting possible increased malignancy risk, which influenced label warnings.

• Limited innovation or reformulation options limit clinical renewal.

• Market saturation in established markets reduces avenues for growth.

• Pricing pressures and reimbursement hurdles restrict sales expansion.

Key Takeaways

• Clinical trials for Becaplermin have largely ceased, with no significant new data or expanded indications on the horizon.

• The global wound healing market is large, valued above $4 billion, but Becaplermin's share remains below 10%.

• Market growth remains slow, averaging 1-2% annually, constrained by safety concerns, competition, and reimbursement issues.

• Future growth hinges on continued demand for diabetic foot ulcer treatment and potential safety or efficacy improvements.

FAQs

1. Are there any ongoing clinical trials aimed at expanding Becaplermin’s indications?
No active or planned Phase III trials focus on new indications. The last significant clinical studies concentrated on safety and comparative effectiveness.

2. How does Becaplermin compare to newer treatments?
It offers growth factor-based wound healing but is challenged by newer biologics, skin substitutes, and advanced dressings that demonstrate superior efficacy or safety profiles.

3. What safety issues have been associated with Becaplermin?
Post-market concerns include potential increased risk of malignancies, leading to label warnings and cautious use.

4. Can Becaplermin's market share increase?
Unlikely, without clinical or regulatory developments. Market share may stabilize or decline further due to competition and safety concerns.

5. What is the outlook for the diabetic foot ulcer treatment market?
Continued demand exists due to rising diabetes prevalence. Innovations and combination therapies could impact future treatment paradigms but not necessarily bolster Becaplermin significantly.

---

Sources:
[1] MarketsandMarkets. Diabetic Foot Ulcers Market, 2021.
[2] IQVIA. Global Wound Care Market Data, 2022.
[3] Frost & Sullivan. Wound Care Market Forecast, 2022.