DICLEGIS (doxylamine succinate)
Diclegis is a combination medication that helps pregnant women manage nausea and vomiting when conservative treatments are not effective. It combines two active ingredients: doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog. This treatment is specifically for those who do not respond to initial lifestyle or dietary changes, though it has not been studied for use in cases of hyperemesis gravidarum.
How DICLEGIS Works
The specific mechanism by which this medication works to alleviate symptoms is unknown. It functions as a fixed-dose combination of an antihistamine and a Vitamin B6 analog.
Details
- Status
- Prescription
- First Approved
- 2013-04-08
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
DICLEGIS Approval History
What DICLEGIS Treats
1 indicationsDICLEGIS is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea and Vomiting of Pregnancy
DICLEGIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02045901 PED-301 | PED-301 | Ph 4 | terminated | A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DICLEGIS FDA Label Details
Indications & Usage
FDA Label (PDF)DICLEGIS is indicated for the treatment of Nausea and Vomiting of Pregnancy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.