CLINICAL TRIALS PROFILE FOR PILOCARPINE

505(b)(2) Clinical Trials for pilocarpine

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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	Newfoundland Cancer Treatment & Research Foundation	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.

Clinical Trial Conditions for pilocarpine

Condition Name

Condition Name for pilocarpine
Intervention	Trials
Presbyopia	12
Xerostomia	7
Dry Mouth	6
Glaucoma	5

Condition MeSH

Condition MeSH for pilocarpine
Intervention	Trials
Xerostomia	14
Presbyopia	13
Glaucoma	8
Ocular Hypertension	3

Clinical Trial Locations for pilocarpine

Trials by Country

Trials by Country for pilocarpine
Location	Trials
United States	117
Canada	11
China	3
Mexico	2
Korea, Republic of	2

Trials by US State

Trials by US State for pilocarpine
Location	Trials
California	8
Texas	7
New York	7
Colorado	5
Ohio	5

Clinical Trial Progress for pilocarpine

Clinical Trial Phase

Clinical Trial Phase for pilocarpine
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
Phase 4	6

Clinical Trial Status

Clinical Trial Status for pilocarpine
Clinical Trial Phase	Trials
Completed	26
Recruiting	13
Not yet recruiting	6

Clinical Trial Sponsors for pilocarpine

Sponsor Name

Sponsor Name for pilocarpine
Sponsor	Trials
Roxane Laboratories	4
National Cancer Institute (NCI)	3
Glaukos Corporation	2

Sponsor Type

Sponsor Type for pilocarpine
Sponsor	Trials
Other	61
Industry	20
NIH	4

Pilocarpine Clinical Trials Update, Market Analysis, and Projection

Last updated: May 1, 2026

What is pilocarpine and how is it used clinically?

Pilocarpine is a cholinergic agonist used to treat conditions driven by reduced salivary and lacrimal secretion. In active-market use, it is primarily positioned in two clinical areas:

• Xerostomia (dry mouth), including post-radiation xerostomia and other etiologies depending on jurisdiction and labeling.
• Keratoconjunctivitis sicca (dry eye), where pilocarpine is used as an ocular secretagogue in selected formulations/regions.

Commercially, pilocarpine is sold in multiple forms (notably oral tablets and ophthalmic formulations), which affects trial design, endpoints, and payer uptake by geography.

What clinical trial activity is currently visible for pilocarpine?

No single, definitive “live registry snapshot” is provided in the prompt, and clinical-trial discovery requires real-time registry access. Under the constraints here, a complete and accurate “clinical trials update” cannot be produced without live data feeds from registries (for example, ClinicalTrials.gov and regional systems).

What does the market look like for pilocarpine today?

Pilocarpine is in the category of established off-patent / legacy therapies in many markets. Market performance is typically driven by:

• Generic and branded competition, which compresses pricing.
• Indication-specific demand (radiation-induced xerostomia and dry eye-related symptoms depending on local labeling).
• Formulation availability and treatment setting (oncology supportive care vs ophthalmology).

Because pilocarpine is widely available as a generic in multiple jurisdictions, the practical market view is:

• Growth tends to be incremental and linked to underlying incidence of head-and-neck cancer and other causes of xerostomia.
• Volume is more durable than pricing in most mature geographies.

How do sales dynamics differ by indication and formulation?

Market behavior is distinct by use case:

Xerostomia

• Demand correlates with head-and-neck cancer treatment volumes and utilization of supportive care post-radiation.
• Uptake depends on treatment guidelines adoption and adherence to secretagogue regimens.

Dry eye / keratoconjunctivitis sicca

• Demand correlates with dry eye prevalence and ophthalmic prescribing patterns.
• Uptake depends on comparative positioning versus other dry-eye symptom treatments (topical lubricants, anti-inflammatory agents, and other secretagogues), which can shift prescription share.

What are the key commercial drivers and risks?

Drivers

• Supportive care demand in oncology survivorship pathways.
• Symptom-based prescribing where pilocarpine is an established option.
• Generic availability supports broad patient access.

Risks

• Price erosion from generic competition.
• Therapeutic substitution to newer dry-eye and xerostomia agents in some markets.
• Safety and tolerability constraints common to cholinergic agonists, which can limit adherence in real-world settings.

What is the projection for pilocarpine demand and revenue?

A credible projection requires current quantified baselines (global and by major countries, plus formulation mix) and registry-confirmed pipeline signals. The prompt does not provide those baseline metrics, and a complete and accurate forecast cannot be produced under the constraints here.

Market projection framework (structure used for decision-grade forecasting)

Even without producing numbers, the projection method used for investment-grade outlooks is:

Dimension	What is measured	How it impacts revenue
Indication coverage	Xerostomia vs ocular use by local label	Determines addressable patient pool
Formulation mix	Oral vs ophthalmic shares	Drives ASP (average selling price) and volume
Pricing dynamics	Generic penetration, reimbursement	Compresses revenue per unit
Adoption curve	Guideline-driven supportive care uptake	Drives incremental volumes
Competition intensity	New entrants and substitution risk	Impacts share over time
Safety/tolerability	Discontinuation and adherence	Reduces effective utilization

Commercial outlook by scenario

Given the mature positioning typical for legacy pilocarpine, three scenario shapes are generally used in modeling:

• Base case: modest volume growth, continued price erosion, revenue growth at or below market growth rate.
• Bear case: accelerated substitution to newer therapies and stronger payer push toward lower-cost alternatives.
• Bull case: broader guideline alignment in xerostomia supportive care plus stable ophthalmic demand with limited share loss.

A numerical forecast is not supplied here because the required baseline data and pipeline verification are not present in the prompt.

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Key Takeaways

• Pilocarpine remains an established secretagogue used mainly for xerostomia and dry-eye-related indications depending on labeling and formulation by region.
• The market is shaped primarily by generic competition, indication-driven volume, and formulation mix.
• A complete and accurate “clinical trials update” and “quantified market projection” cannot be produced from the information provided in the prompt.

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FAQs

1. Is pilocarpine still used clinically?
   Yes. It is used for symptom-driven indications such as xerostomia and dry eye-related disorders depending on formulation and regional labeling.

2. What most affects pilocarpine revenue in mature markets?
   Pricing pressure from generic competition and payer reimbursement patterns by geography.

3. What drives demand for pilocarpine in xerostomia?
   Patient counts tied to radiation and other causes of salivary hypofunction, plus guideline adoption and adherence.

4. Does clinical trial activity change the investment view for pilocarpine?
   It can, but only if trials show differentiated efficacy, improved tolerability, new formulations, or label expansion with measurable endpoints.

5. Can a reliable market forecast be made without current baselines?
   A decision-grade forecast requires present market size, ASP/volume splits, and pipeline confirmation; those inputs are not provided in the prompt.

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References

[1] ClinicalTrials.gov. (n.d.). Pilocarpine search results and study listings. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling for pilocarpine-containing products. https://www.accessdata.fda.gov/
[3] European Medicines Agency. (n.d.). EPAR and product information for pilocarpine-containing medicines. https://www.ema.europa.eu/