NDAORALTABLET, DELAYED RELEASE
Approved
Apr 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DICLEGIS is a delayed-release oral tablet combining doxylamine succinate (a sedating antihistamine) and pyridoxine hydrochloride (vitamin B6) indicated for nausea and vomiting of pregnancy (NVP). The combination leverages doxylamine's antiemetic properties and pyridoxine's independent efficacy in pregnancy-related nausea. It is the first and only FDA-approved medication specifically formulated for morning sickness.
$0.017BPart D
PeakModest Part D utilization suggests a niche but stable market; small brand team likely focused on maintaining category awareness and provider education.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
Started Feb 2014
131 enrolled
Morning Sickness
Career Relevance
Working on DICLEGIS offers exposure to women's health and obstetric markets, with emphasis on formulary navigation, payer strategy, and pregnancy safety communications. Limited clinical development activity means career impact centers on commercial execution, market access problem-solving, and provider relationship management in a specialized therapeutic area.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.