Doxepin Hydrochloride

(Doxepin)

ApprovedSmall molecule

Doxepin Hydrochloride is one of 201 small molecule programs targeting Nasopharyngeal Carcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

200

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Nasopharyngeal CarcinomaActive, not recruiting

InsomniaActive, not recruiting

UrticariaActive, not recruiting

Irritable Bowel SyndromeActive, not recruiting

Bipolar DisorderActive, not recruiting

Nasopharyngeal CarcinomaPreclinical

Active, not recruiting

InsomniaPhase 2

Active, not recruiting

UrticariaPhase 3

Active, not recruiting

Irritable Bowel SyndromePhase 2

Active, not recruiting

Bipolar DisorderPreclinical

Active, not recruiting

Competition

Competitive Landscape

282 competitors in Nasopharyngeal Carcinoma

#DrugCompanyPhaseTrials

Gemzar

Johnson & Johnson

Phase 3

34 2

Doxepin Hydrochloride

CCurrax Pharmaceuticals

Approved

10 3

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

21 4

Taxotere

AAvyxa

Phase 3

16 5

Tuoyi

SSun Yat-sen University

Phase 3

11 6

Theraplaza

BBiotech Pharmaceutical Co., Ltd.

Phase 3

10 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Phase 3

6 8

Erbitux

IImclone

Phase 3

4 9

Adrucil

EElorac, Inc.

Phase 3

3 10

Induction Phase1

Genmab

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

PreclinicalRecruiting

Pain

NCT06017895

Clinical

Trials by Indication[1]

Insomnia2 trials

The Treatment of Insomnia in Patients With HIV Disease

Completed·—·Phase 4·NCT00465972·44 enrolled

Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia

Completed· Takeda logo

Takeda·Phase 2·NCT00755495·472 enrolled

Pruritus1 trial

Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

Completed·—·Phase 4·NCT03758079·14 enrolled

Urticaria1 trial

Using Doxepin for Urticaria

Unknown status·SState University of New York - Upstate Medical University·Phase 3·NCT05115136·160 enrolled

Irritable Bowel Syndrome1 trial

Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Completed·—·Phase 2·NCT01268709

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

3 more indications

Interaction1 trial

Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor

Completed·—·N/A·NCT04554888·20 enrolled

Pain1 trial

Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patient Receiving Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Controlled, Double-Blind Clinical Trial

Recruiting·NNanfang Hospital, Southern Medical University·Preclinical·NCT06017895·178 enrolled

Unspecified2 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch

Completed·—·N/A·NCT04588532·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

DOXEPIN HYDROCHLORIDE

NDA NDA016987

Jan 1, 1982

SINEQUAN

NDA NDA016798

Jan 1, 1982

SINEQUAN

NDA NDA017516

Apr 1, 1994

ZONALON

NDA NDA020126

Mar 17, 2010

SILENOR

NDA NDA022036

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Doxepin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Doxepin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Doxepin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022036). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Doxepin Hydrochloride. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Currax Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCurrax Pharmaceuticals

Patent Landscape[5]

Patent Cliff

May 18, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9486437May 18, 2027

9861607May 18, 2027

12083090May 18, 2027

10238620May 18, 2027

10653662May 18, 2027

11 more patents

10653660Jul 20, 2027

11110074Jul 20, 2027

9572814Jul 20, 2027

7915307Aug 24, 2027

11234954Jan 18, 2028

10548871Apr 11, 2028

9907780Apr 11, 2028

11096920Apr 11, 2028

9107898May 1, 2028

9532971Jun 1, 2029

8513299Sep 7, 2030

Doxepin Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Insomnia2 trials

Pruritus1 trial

Urticaria1 trial

Irritable Bowel Syndrome1 trial

Bipolar Disorder1 trial

Interaction1 trial

Pain1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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