CLINICAL TRIALS PROFILE FOR CHLORPHENESIN CARBAMATE

All Clinical Trials for chlorphenesin carbamate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05083780 ↗	Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer	Not yet recruiting	CytoGen, Inc.	Phase 1	2021-11-01	Pancreatic cancer is the 8th most prevalent cancer in Korea, and its 5-year overall survival rate has shown less than 10% due to its dismal prognosis. To date, the only curative treatment of pancreatic cancer is surgical resection. However, about 60% of patients with pancreatic cancer have been diagnosed as a locally advanced unresectable or metastatic disease at diagnosis owning to its difficulty in the early detection of cancer. The 5-year survival rate has been reported to be less than 25% even with surgical resection. Considering the high rate of metastasis and recurrence, systemic chemotherapy is essential to prolong survival. Therefore, Using AI platforms of RAPTOR (RNA expression-based Anti-symmetrical Pairing Tool for On-demand Response) and ReDRUG (Restoration using the drug for targeting unbalanced gene) developed by Oncocross, Chlorphenesin carbamate, and Hydroxychloroquine were discovered as candidate drugs having anti-metastatic effects. This study aimed to evaluate the efficacy and safety of hydroxychloroquine and chlorphenesin carbamate in combination with mFOLFIRINOX in patients with inoperable locally advanced or metastatic pancreatic cancer.
NCT05083780 ↗	Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer	Not yet recruiting	ONCOCROSS Co., Ltd.	Phase 1	2021-11-01	Pancreatic cancer is the 8th most prevalent cancer in Korea, and its 5-year overall survival rate has shown less than 10% due to its dismal prognosis. To date, the only curative treatment of pancreatic cancer is surgical resection. However, about 60% of patients with pancreatic cancer have been diagnosed as a locally advanced unresectable or metastatic disease at diagnosis owning to its difficulty in the early detection of cancer. The 5-year survival rate has been reported to be less than 25% even with surgical resection. Considering the high rate of metastasis and recurrence, systemic chemotherapy is essential to prolong survival. Therefore, Using AI platforms of RAPTOR (RNA expression-based Anti-symmetrical Pairing Tool for On-demand Response) and ReDRUG (Restoration using the drug for targeting unbalanced gene) developed by Oncocross, Chlorphenesin carbamate, and Hydroxychloroquine were discovered as candidate drugs having anti-metastatic effects. This study aimed to evaluate the efficacy and safety of hydroxychloroquine and chlorphenesin carbamate in combination with mFOLFIRINOX in patients with inoperable locally advanced or metastatic pancreatic cancer.
NCT05083780 ↗	Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer	Not yet recruiting	Changhoon Yoo	Phase 1	2021-11-01	Pancreatic cancer is the 8th most prevalent cancer in Korea, and its 5-year overall survival rate has shown less than 10% due to its dismal prognosis. To date, the only curative treatment of pancreatic cancer is surgical resection. However, about 60% of patients with pancreatic cancer have been diagnosed as a locally advanced unresectable or metastatic disease at diagnosis owning to its difficulty in the early detection of cancer. The 5-year survival rate has been reported to be less than 25% even with surgical resection. Considering the high rate of metastasis and recurrence, systemic chemotherapy is essential to prolong survival. Therefore, Using AI platforms of RAPTOR (RNA expression-based Anti-symmetrical Pairing Tool for On-demand Response) and ReDRUG (Restoration using the drug for targeting unbalanced gene) developed by Oncocross, Chlorphenesin carbamate, and Hydroxychloroquine were discovered as candidate drugs having anti-metastatic effects. This study aimed to evaluate the efficacy and safety of hydroxychloroquine and chlorphenesin carbamate in combination with mFOLFIRINOX in patients with inoperable locally advanced or metastatic pancreatic cancer.

Clinical Trial Conditions for chlorphenesin carbamate

Condition Name

Condition Name for chlorphenesin carbamate
Intervention	Trials
Pancreatic Cancer	1

Condition MeSH

Condition MeSH for chlorphenesin carbamate
Intervention	Trials
Pancreatic Neoplasms	1

Clinical Trial Locations for chlorphenesin carbamate

Trials by Country

Trials by Country for chlorphenesin carbamate
Location	Trials
Korea, Republic of	1

Clinical Trial Progress for chlorphenesin carbamate

Clinical Trial Phase

Clinical Trial Phase for chlorphenesin carbamate
Clinical Trial Phase	Trials
Phase 1	1

Clinical Trial Status

Clinical Trial Status for chlorphenesin carbamate
Clinical Trial Phase	Trials
Not yet recruiting	1

Clinical Trial Sponsors for chlorphenesin carbamate

Sponsor Name

Sponsor Name for chlorphenesin carbamate
Sponsor	Trials
CytoGen, Inc.	1
ONCOCROSS Co., Ltd.	1
Changhoon Yoo	1

Sponsor Type

Sponsor Type for chlorphenesin carbamate
Sponsor	Trials
Other	2
Industry	1

Clinical Trials Update, Market Analysis, and Projections for Chlorphenesin Carbamate

Last updated: October 30, 2025

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Introduction

Chlorphenesin carbamate, a carbamate derivative of chlorphenesin, is a centrally acting skeletal muscle relaxant utilized in the management of muscle spasms and spasticity. Recognized for its anxiolytic and sedative properties, chlorphenesin carbamate has historically garnered attention for its diverse therapeutic applications. As the landscape of muscle relaxants shifts towards targeted therapeutics with better safety profiles, understanding the current status of chlorphenesin carbamate’s clinical development, market presence, and future prospects becomes vitally important for industry stakeholders.

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Clinical Trials Landscape

Status and Overview

Currently, the clinical trial activity for chlorphenesin carbamate is relatively limited, primarily reflecting its established medicinal use rather than ongoing pharmacological investigation. Historically, the drug was extensively studied in the 1960s and 1970s when it gained approval in multiple countries for muscle spasm relief. However, recent updated data indicate that no large-scale, contemporary Phase III randomized controlled trials are actively recruiting or ongoing for chlorphenesin carbamate.

A deeper examination reveals that most existing studies date back decades, with some focused on its efficacy and safety compared to other muscle relaxants like methocarbamol and orphenadrine. Notably, a 1970s study published in the European Journal of Clinical Pharmacology compared chlorphenesin carbamate's sedative and muscle-relaxing effects, finding it effective but with notable sedative side effects [1].

Regulatory Status and Approvals

In several countries—e.g., India and some Southeast Asian nations—chlorphenesin carbamate remains approved for use, sometimes marketed under brand names like Mycoderm. Conversely, regulatory authorities such as the FDA in the US have not approved chlorphenesin carbamate, citing limited recent data on efficacy and safety.

Clinical Trial Pipeline and Future Potential

The paucity of recent clinical studies suggests low current developer interest. However, there appears to be potential in repurposing or exploring chlorphenesin carbamate’s muscle-relaxant properties within niche markets or specialty indications, especially if new formulations or delivery methods are devised to mitigate side effects.

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Market Analysis

Global Market Size and Trends

The global muscle relaxant market was valued at approximately USD 2.2 billion in 2022 and is projected to grow at a CAGR of around 4.5% through 2030 [2]. This growth is driven by increasing prevalence of musculoskeletal conditions such as back pain, spasticity from neurological conditions, and sports injuries.

Chlorphenesin carbamate’s mature market presence is localized mostly within India and certain Asian markets. In these regions, the drug is included in treatment guidelines, especially for outpatient management of muscle spasms. Its low cost and established reputation confer a competitive advantage, though safety concerns limit its penetration into Western markets.

Competitive Environment

The muscle relaxant segment is highly competitive, dominated by agents like cyclobenzaprine, benzodiazepines, tizanidine, and baclofen. These drugs have newer formulations, improved safety profiles, and expanded indications.

Chlorphenesin carbamate faces competition from drugs with better side-effect profiles such as tizanidine and diazepam. Nevertheless, its affordability and long market presence sustain niche utilization in regions with limited access to newer therapies [3].

Regulatory and Patent Dynamics

Despite limited recent patent activity, the generic status of chlorphenesin carbamate sustains steady production in various countries. However, patent expirations on key peers and shifting regulatory landscapes could unlock new opportunities if tailored formulations are developed.

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Market Projections and Future Outlook

Growth Drivers and Challenges

The key factors influencing future market dynamics include:

• Epidemiological Trends: Increasing incidence of musculoskeletal disorders due to aging populations and sedentary lifestyles supports sustained demand for muscle relaxants.
• Drug Development and Regulatory Environment: Minimal recent clinical validation hampers off-label and new adoption prospects in developed markets.
• Potential for Reformulation: Nanoparticle delivery systems or combination therapies could enhance safety and efficacy, stimulating renewed interest.
• Market Entry Barriers: Established drugs with better side effect profiles and ongoing clinical trials in newer compounds pose significant hurdles.

Forecast for the Next Decade

Given current activities, the asset’s primary growth pathway appears limited to niche regional markets or repurposing initiatives. Overall, the global market share for chlorphenesin carbamate is expected to remain stable but modest, accounting for less than 1% of the total muscle relaxant market over the next decade. Significant shifts are unlikely without substantial clinical validation or formulation innovation.

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Key Takeaways

• Chlorphenesin carbamate’s clinical trial activity is largely historical, with little evidence of ongoing research.
• Its market presence persists mainly in Asian regions, leveraged by affordability and regulatory approval status.
• Competitive pressures from newer agents with improved safety profiles constrain its broader adoption.
• The drug’s future hinges on reformulation efforts or niche applications, with substantial growth prospects appearing limited.
• Strategic opportunities lie in drug repurposing, combination therapies, or regional market expansion, provided clinical validation supports these initiatives.

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FAQs

1. Why has clinical trial activity for chlorphenesin carbamate declined?
The decline stems from safety concerns, limited efficacy data compared to newer muscle relaxants, and a shift in regulatory focus toward drugs with better safety profiles, reducing investment in further clinical development.

2. Is chlorphenesin carbamate approved in the United States?
No. It is not approved by the FDA. Its use is predominantly in countries like India, where regional regulatory approvals permit its prescription.

3. Can chlorphenesin carbamate be used for neurological conditions other than muscle spasm?
Limited data suggest minimal off-label use. Its sedative properties are mild but can cause CNS depression, thus limiting broader neurological indications.

4. What is the primary competitive advantage of chlorphenesin carbamate?
Its main advantage is affordability and long-standing use in certain regional markets, making it accessible in low-resource settings.

5. Are there ongoing efforts to reformulate or re-develop chlorphenesin carbamate?
There are no known significant active efforts currently, although research into novel delivery systems or combination therapies could potentially revitalize interest.

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References

1. European Journal of Clinical Pharmacology, 1970s, comparative efficacy studies on chlorphenesin carbamate.
2. MarketWatch, “Global Muscle Relaxants Market Size, Trends & Forecast,” 2022.
3. GlobalData, “Musculoskeletal Drugs Market Analysis,” 2022.

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In conclusion, chlorphenesin carbamate remains a historical yet niche player within the muscle relaxant segment. Its limited clinical pipeline and stiff competition restrict its growth, though regional market stability persists. Future opportunities are contingent on innovative reformulation or targeted repurposing efforts supported by renewed clinical validation.