Drugs / Doxylamine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) DECAPRYN 1948-04-07 fda.gov

Trials 5 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00796315 Dec 2008 → Jun 2009 allergic rhinitis, respiratory tract infectious disorder Procter and Gamble Completed No outcome recorded
Phase 33 trials
Phase 3 NCT04401384 Jun 2020 → Jun 2021 hyperemesis gravidarum Xiaoke Wu Completed No outcome recorded
Phase 3 NCT00857987 Apr 2010 → Oct 2011 respiratory tract infectious disorder Azidus Brasil Unknown No outcome recorded
Phase 3 NCT00614445 Jan 2008 → Jul 2009 hyperemesis gravidarum Duchesnay Inc. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT06716645 Dec 2024 → Feb 2025 common cold HALEON Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
NCT07354529 Comparator Jun 2025 → Jan 2026 overdue pregnancy disorder Bahria University Active not recruiting No outcome recorded
NCT06772974 Comparator Jan → Jun 2025 overdue hyperemesis gravidarum Nawaz Sharif Medical College Not yet recruiting No outcome recorded
NCT06259747 Background Feb → Dec 2023 hyperemesis gravidarum Kafrelsheikh University Completed No outcome recorded

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Doxylamine “Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg) , 2-4 tablets/day)” NCT04401384
5

“Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup” NCT00857987

NCT07354529

NCT00796315

NCT06772974

NCT06259747

Known as Alsodorm ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Decapryn ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Donormil ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Donormyl ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Dormidina ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Doxilamina ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Doxy-sleep-aid ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Doxylamine hydrogen succinate ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as doxylamine succinate “Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg) , 2-4 tablets/day)” NCT04401384
3

“Dextromethorphan Hydrobromide, USP 30 mg and Doxylamine Succinate, USP 12.5 mg” NCT06716645

“Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup” NCT00857987

NCT00614445

Known as Doxylamine succinate component of bendectin ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Doxylamine succinate component of bonjesta ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Doxylamine succinate component of diclectin ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Doxylamine succinate component of diclegis ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Gittalun ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Hoggar n ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Meraprina ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as NSC-74772 ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Known as Succinate doxilamine “Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.” NCT00857987
Known as Unisom ChEMBL registry synonym — accepted as the source's own label CHEMBL1004
Action Inhibit “Histamine H1 receptor antagonist” CHEMBL1004
Modality Small molecule CHEMBL1004
Route Oral “initial oral dose of 2 tablets at bedtime” NCT04401384
Target HRH1 “Histamine H1 receptor antagonist” CHEMBL1004