CLINICAL TRIALS PROFILE FOR PILOCARPINE HYDROCHLORIDE

505(b)(2) Clinical Trials for pilocarpine hydrochloride

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
OTC	NCT02935894 ↗	Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat	Completed	University of California, Davis	N/A	2016-11-28	The purpose of this study is to see what the differences are in sweat (amount and small molecule content) collected from different sites of the body and by different methods of sweat stimulation. Additionally, the investigators want to know whether the amount and small molecule content of the sweat is the same in an individual over time, and the same across individuals at a given time. Finally, the investigators want to know how consumption of over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory mediator content of sweat and how that compares to blood. This information will help to better understand the composition and behavior of sweat and assess its potential utility as a routine clinical tool in skin research.
OTC	NCT02935894 ↗	Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat	Completed	USDA, Western Human Nutrition Research Center	N/A	2016-11-28	The purpose of this study is to see what the differences are in sweat (amount and small molecule content) collected from different sites of the body and by different methods of sweat stimulation. Additionally, the investigators want to know whether the amount and small molecule content of the sweat is the same in an individual over time, and the same across individuals at a given time. Finally, the investigators want to know how consumption of over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory mediator content of sweat and how that compares to blood. This information will help to better understand the composition and behavior of sweat and assess its potential utility as a routine clinical tool in skin research.

All Clinical Trials for pilocarpine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00168181 ↗	Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients	Completed	CancerCare Manitoba	Phase 3	2002-04-01	This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.
NCT00168181 ↗	Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients	Completed	Jewish General Hospital	Phase 3	2002-04-01	This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.
NCT00003686 ↗	Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids	Terminated	NCIC Clinical Trials Group	Phase 3	1998-05-22	RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer therapy. It is not yet known whether pilocarpine is more effective than no further treatment for this condition. PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have dry mouth caused by opioids.
NCT00003139 ↗	Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1998-03-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy. It is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer. PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.
NCT00003139 ↗	Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer	Completed	Radiation Therapy Oncology Group	Phase 3	1998-03-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy. It is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer. PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.

Clinical Trial Conditions for pilocarpine hydrochloride

Condition Name

Condition Name for pilocarpine hydrochloride
Intervention	Trials
Presbyopia	10
Xerostomia	6
Dry Mouth	6
Glaucoma	5

Condition MeSH

Condition MeSH for pilocarpine hydrochloride
Intervention	Trials
Xerostomia	13
Presbyopia	11
Glaucoma	8
Head and Neck Neoplasms	3

Clinical Trial Locations for pilocarpine hydrochloride

Trials by Country

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Trials by Country for pilocarpine hydrochloride
Location	Trials
United States	113
Canada	11
Taiwan	2
United Kingdom	2
Brazil	2

Trials by US State

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−

Trials by US State for pilocarpine hydrochloride
Location	Trials
California	7
New York	7
Texas	7
Ohio	5
Colorado	5

Clinical Trial Progress for pilocarpine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for pilocarpine hydrochloride
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	14
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for pilocarpine hydrochloride
Clinical Trial Phase	Trials
Completed	24
Recruiting	10
Not yet recruiting	6

Clinical Trial Sponsors for pilocarpine hydrochloride

Sponsor Name

Sponsor Name for pilocarpine hydrochloride
Sponsor	Trials
Roxane Laboratories	4
National Cancer Institute (NCI)	3
Ocuphire Pharma, Inc.	2

Sponsor Type

Sponsor Type for pilocarpine hydrochloride
Sponsor	Trials
Other	55
Industry	18
NIH	4

Pilocarpine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Pilocarpine Hydrochloride

Pilocarpine hydrochloride is a cholinergic muscarinic agonist widely used in the treatment of various ophthalmic and oral health conditions. It is known for its ability to reduce intraocular pressure and stimulate salivation, making it a crucial medication for patients with glaucoma, dry mouth (xerostomia), and presbyopia.

Clinical Trials Update

Presbyopia Treatment

Recent clinical trials have highlighted the efficacy and safety of pilocarpine hydrochloride in treating presbyopia. A notable study involved CSF-1, a 0.4% pilocarpine hydrochloride ophthalmic solution, which was evaluated in two Phase 3 multicenter, randomized, double-masked, vehicle-controlled trials. These trials, conducted from October 2020 to February 2022, included 613 participants and demonstrated that CSF-1 significantly improved near vision in individuals with presbyopia without compromising distance vision. The primary endpoint showed that 40.1% of the CSF-1 group achieved a response, compared to 19.1% of the vehicle group, with a favorable safety profile and no serious or severe adverse events reported[2].

Another significant development is the FDA approval of QLOSI (0.4% pilocarpine hydrochloride ophthalmic solution) by Orasis Pharmaceuticals in October 2023. QLOSI is expected to launch in the latter half of 2024, offering a non-surgical treatment option for presbyopia[4].

Market Analysis

Market Size and Growth

The pilocarpine hydrochloride market is experiencing robust growth driven by several factors. As of 2023, the market size was valued at USD 167.37 million and is projected to reach USD 1,698.22 million by 2031, growing at a CAGR of 39.24% from 2024 to 2031[5].

Another report indicates that the market size was valued at USD 99.87 billion in 2023 and is expected to reach USD 184.67 billion by 2030, with a CAGR of 8.74% from 2024 to 2030. This growth is attributed to the increasing demand for pilocarpine hydrochloride across various applications globally[1].

Key Drivers

The growth of the pilocarpine hydrochloride market is driven by several key factors:

• Increasing Prevalence of Age-Related Conditions: The rising prevalence of conditions such as glaucoma and dry mouth (xerostomia) among the elderly population is a significant driver. According to the World Health Organization, approximately 76 million people aged 40 to 80 worldwide are affected by glaucoma, and this number is expected to rise as the aging population grows[5].
• Advancements in Healthcare Infrastructure: Improved healthcare infrastructure in developing regions has enhanced access to medications, contributing to market expansion[5].
• Growing Awareness: Increasing awareness about the importance of early diagnosis and treatment of eye disorders and oral health issues has prompted greater adoption of effective medications like pilocarpine hydrochloride[5].

Market Segmentation

By Product Type

The market is segmented into ophthalmic solutions and oral drugs. In 2023, oral drugs accounted for the largest market share of 62.78%, with a market value of USD 77.97 million and a projected CAGR of 4.66% during the forecast period. Ophthalmic solutions were the second-largest segment[5].

By Distribution Channel

The market is segmented into retail pharmacy, hospital pharmacy, and online pharmacy. Retail pharmacies accounted for the biggest market share of 61.19% in 2023, with a market value of USD 75.99 million and a projected CAGR of 38.27% during the forecast period. Hospital pharmacies were the second-largest segment[5].

By Geography

The global pilocarpine hydrochloride market is bifurcated into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. The U.S. accounted for the largest market share of 90.52% in 2023, with a market value of USD 53.54 million and a projected CAGR of 38.86% during the forecast period[5].

Market Projections

Future Growth

The pilocarpine hydrochloride market is expected to experience substantial growth over the forecast period. The launch of new treatments, such as QLOSI, and the ongoing development of other therapies like Phentolamine Ophthalmic Solution 0.75% by Viatris and Ocuphire Pharma, are poised to transform the market landscape. These emerging therapies are expected to reshape the presbyopia market, offering new standards of care and unlocking opportunities for medical innovation and economic growth[4].

Competitive Landscape

The market is dominated by several key players, including Pfizer, Novartis AG, AstraZeneca PLC, Akorn, Genexine, and Bristol-Myers Squibb Company. These companies are actively involved in research and development to enhance the efficacy and safety of pilocarpine hydrochloride formulations[1].

Key Takeaways

• Clinical Trials Success: Recent clinical trials have demonstrated the efficacy and safety of pilocarpine hydrochloride in treating presbyopia.
• Market Growth: The market is expected to grow significantly, driven by the increasing prevalence of age-related conditions and advancements in healthcare infrastructure.
• Segmentation: The market is segmented by product type, distribution channel, and geography, with oral drugs and retail pharmacies being the largest segments.
• Future Projections: The launch of new treatments and ongoing developments are expected to transform the market landscape and drive future growth.

FAQs

What is pilocarpine hydrochloride used for?

Pilocarpine hydrochloride is used to treat various conditions, including glaucoma, dry mouth (xerostomia), and presbyopia. It works by reducing intraocular pressure and stimulating salivation.

What are the recent clinical trial findings for pilocarpine hydrochloride in presbyopia?

Recent clinical trials have shown that pilocarpine hydrochloride ophthalmic solutions, such as CSF-1 and QLOSI, significantly improve near vision in individuals with presbyopia without compromising distance vision.

What is the projected market size of pilocarpine hydrochloride by 2031?

The pilocarpine hydrochloride market is projected to reach USD 1,698.22 million by 2031, growing at a CAGR of 39.24% from 2024 to 2031.

Who are the key players in the pilocarpine hydrochloride market?

Key players include Pfizer, Novartis AG, AstraZeneca PLC, Akorn, Genexine, and Bristol-Myers Squibb Company.

What are the main drivers of the pilocarpine hydrochloride market growth?

The main drivers include the increasing prevalence of age-related conditions, advancements in healthcare infrastructure, and growing awareness about early diagnosis and treatment of eye and oral health issues.

Sources

1. Verified Market Reports: Pilocarpine Hydrochloride Market Size, Forecast [2030][1]
2. PubMed: Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Individuals with Presbyopia[2]
3. Market Research Intellect: Global Pilocarpine Hydrochloride Market Size, Trends and Projections[3]
4. PR Newswire: Presbyopia Treatment Market Set to Reach New Heights with New Therapies and Advancements by 2034[4]
5. Verified Market Research: Pilocarpine Hydrochloride Market Size, Share, Trends & Forecast[5]