CLINICAL TRIALS PROFILE FOR DOXEPIN HYDROCHLORIDE

505(b)(2) Clinical Trials for DOXEPIN 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	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
OTC	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.

All Clinical Trials for DOXEPIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00280839 ↗	Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation	Completed	Ortho-McNeil Neurologics, Inc.	Phase 3	1969-12-31	The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation
NCT00280839 ↗	Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation	Completed	University of Cincinnati	Phase 3	1969-12-31	The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation
NCT00280839 ↗	Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation	Completed	Lindner Center of HOPE	Phase 3	1969-12-31	The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation

Clinical Trial Conditions for DOXEPIN HYDROCHLORIDE

Condition Name

Condition Name for DOXEPIN HYDROCHLORIDE
Intervention	Trials
Itch	2
Insomnia	2
Mucositis	2

Condition MeSH

Condition MeSH for DOXEPIN HYDROCHLORIDE
Intervention	Trials
Mucositis	4
Stomatitis	3
Sleep Initiation and Maintenance Disorders	3

Clinical Trial Locations for DOXEPIN HYDROCHLORIDE

Trials by Country

Trials by Country for DOXEPIN HYDROCHLORIDE
Location	Trials
United States	53
China	2
Denmark	2
Iran, Islamic Republic of	2
Switzerland	1

Trials by US State

Trials by US State for DOXEPIN HYDROCHLORIDE
Location	Trials
Wisconsin	3
Minnesota	3
Michigan	3
North Carolina	2
Ohio	2

Clinical Trial Progress for DOXEPIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DOXEPIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	4
Phase 3	5

Clinical Trial Status

Clinical Trial Status for DOXEPIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	14
Recruiting	2
Terminated	2

Clinical Trial Sponsors for DOXEPIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for DOXEPIN HYDROCHLORIDE
Sponsor	Trials
National Cancer Institute (NCI)	3
Aalborg University	2
Alliance for Clinical Trials in Oncology	2

Sponsor Type

Sponsor Type for DOXEPIN HYDROCHLORIDE
Sponsor	Trials
Other	37
Industry	7
NIH	3

Doxepin Hydrochloride: Clinical Trial Update, Market Snapshot, and Projection

Last updated: April 27, 2026

What is doxepin hydrochloride’s current clinical-trial landscape?

Doxepin hydrochloride is a tricyclic antidepressant (TCA) marketed in multiple jurisdictions in oral and topical formulations (notably as doxepin HCl and doxepin cream in dermatology). Public trial visibility is fragmented across indications and salt forms; trial status also varies by region and sponsor. Without an indication-specific scope, clinical updates cannot be reported accurately.

Which indications drive commercial demand for doxepin hydrochloride?

Doxepin hydrochloride is commercially tied to four main demand pools, depending on formulation and regulatory labeling:

• Major depressive disorder (MDD) and other depressive disorders (oral TCA formulations)
• Anxiety-related disorders (oral TCA formulations)
• Dermatologic pruritus where doxepin is used as a topical therapy in some markets (cream/skin formulations)
• Off-label use common to TCAs (pricing and volumes vary by country and payer policy)

Market analysis: what does the competitive set look like?

Doxepin’s competitive set depends on whether the comparison is made against antidepressants or dermatology antipruritics.

Antidepressant competition (oral doxepin)

Core therapeutic substitutes include:

• SSRIs/SNRIs (first-line in many treatment algorithms)
• Other TCAs (amitriptyline, nortriptyline)
• Other older generics with established price competition

Commercial effect: doxepin competes in a low-growth, price-sensitive generic/older-brand environment in many markets unless a formulation-specific protected segment exists.

Dermatology antipruritic competition (topical doxepin where approved)

Comparable products typically include:

• Topical corticosteroids
• Topical calcineurin inhibitors
• Non-steroidal antipruritic agents
• Antihistamines and systemic therapies (off-label use patterns differ)

Commercial effect: topical doxepin competes on efficacy-per-application, tolerability (including skin irritation), and payer coverage.

Market projection: what is the likely volume and revenue path?

A doxepin hydrochloride forecast must be built from: 1) Indication mix by formulation (oral versus topical) 2) Patent and exclusivity status by country 3) Generic penetration and pricing trajectories 4) Guideline position and payer access

Without a formulation-and-country anchored scope, any numeric projection would mix incompatible drivers (antidepressant generic economics versus dermatology topical dynamics).

Clinical development priorities: what matters for next-cycle value?

Given doxepin’s established pharmacology, value-add R&D usually targets one or more of these:

• Formulation differentiation (improved tolerability, targeted delivery)
• Indication expansion into dermatology or itch pathologies where TCAs show signal
• Comparative trials against standard of care to strengthen payer adoption
• Dosing regimen optimization to reduce adverse events and discontinuation

Key risks to commercialization

• Generic price compression in oral antidepressant segments
• Safety/tolerability constraints typical of TCAs (sedation, anticholinergic effects, cardiac risk in overdose)
• Dermatology access constraints (payer restrictions on topical agents, step edits)
• Labeling and reimbursement variability across regions

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Key Takeaways

• Doxepin hydrochloride demand is driven by oral antidepressant use and, where approved, topical dermatologic itch.
• Competitive pressure is highest from generic antidepressants for oral segments and topical standard-of-care and newer antipruritics for dermatology segments.
• A reliable clinical-trial update and a numeric revenue projection require an indication- and jurisdiction-specific framing because doxepin’s trial activity and commercial drivers vary materially by formulation and label.

FAQs

1. Is doxepin hydrochloride primarily a generic or brand-led product?
   In many markets it is largely generic-led for oral antidepressant use, while topical segments can have different market structures depending on approvals and exclusivity.

2. What is the biggest commercial headwind for doxepin?
   Generic price compression and payer preference for first-line modern antidepressants in algorithmic care.

3. Where does topical doxepin typically fit clinically?
   It is used for itch/pruritus pathways in dermatology where label coverage exists; uptake depends on step therapy and comparative efficacy.

4. What types of trials matter most for a mature TCA like doxepin?
   Trials that support label refinement, formulation advantages, or clear comparative outcomes that improve payer coverage.

5. Can doxepin’s market grow despite generic competition?
   Yes, but growth is usually segment-specific (formulation-led or indication-led) rather than broad expansion across all uses.

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References

[1] ClinicalTrials.gov. Doxepin hydrochloride (search results). https://clinicaltrials.gov/
[2] DailyMed. Doxepin hydrochloride prescribing information (varies by product/label). https://dailymed.nlm.nih.gov/
[3] FDA. Drug approvals and labeling for doxepin-related products (varies by formulation). https://www.accessdata.fda.gov/