NDAORALTABLET, DELAYED RELEASE
Approved
Apr 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Drug data last refreshed 6h 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) for the treatment of nausea and vomiting of pregnancy (NVP). The combination leverages doxylamine's antihistamine properties and pyridoxine's independent anti-nausea effects to address pregnancy-related morning sickness. It is the only FDA-approved medication specifically indicated for NVP.
$0.017BPart D
PeakEstablished peak-stage product with stable but modest Medicare utilization; brand team likely focused on market maintenance rather than expansion.
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
Diclegis roles focus on commercial execution in a niche, specialized therapeutic area with a defined patient population and limited competitors. Career advancement on this product emphasizes market access, physician relationship management, and pregnancy-specific clinical expertise rather than launching new mechanisms or expanding indications.
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.