Wednesday, July 8, 2026

Drug profile · INN

doxylamine succinate

doxylamine succinate (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Quantum Biopharma. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 14
Pipeline programs 6
News articles 0
Drug details — doxylamine succinate
US status
approved
Class
Route
ORAL
Patents
14
Programs
6
Data quality
0.89

Quick answer

doxylamine succinate (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Quantum Biopharma. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN doxylamine succinate
Brand DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Mechanism Histamine H1 receptor antagonist
Target Histamine H1 receptor
Route ORAL
Formulation TABLET, EXTENDED RELEASE

Mechanism of action

Histamine H1 receptor antagonist

Primary target: Histamine H1 receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. NN7533-4470 Phase 2 · NovoThirteen · Sickle cell disease
  2. sodium oxybate Approved · Jazz Pharmaceuticals Ireland · Sleep
  3. 24/7 EEG™ SubQ Unknown · Cognition Therapeutics · Sleep
  4. BEAM Dream Powder Unknown · Beam Therapeutics · Sleep
  5. Beam Organics Dream Powder Unknown · Beam Therapeutics · Sleep
  6. Kava (Piper methysticum) extract Unknown · First People's Hospital · Sleep

Related & competitor drugs

  1. azelastine hydrochloride Histamine H1 receptor antagonist
  2. brompheniramine maleate Histamine H1 receptor antagonist
  3. carbinoxamine maleate Histamine H1 receptor antagonist
  4. cetirizine hydrochloride Histamine H1 receptor antagonist
  5. chlorpheniramine maleate Histamine H1 receptor antagonist
  6. clemastine fumarate Histamine H1 receptor antagonist
  1. US 12377151

    Immobilized endoglycosidase fusion protein and use thereof

    Expires Mon Jul 31 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12370266

    Polymer composite nanomaterial encapsulation system

    Expires Mon Jul 24 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12312377

    Biconjugatable labels and methods of use

    Expires Mon May 22 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12195454

    Compounds for imaging tau proteins that accumulate in the brain

    Expires Mon Jan 09 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12102694

    Radiolabeled compound producing method and producing apparatus, radiolabeled compound and radioisotope producing apparatus

    Expires Mon Sep 26 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11834688

    Ligase fusion proteins and application thereof

    Expires Mon Nov 30 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11826432

    Linkers, conjugates and applications thereof

    Expires Mon Nov 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11667628

    Compounds for imaging tau proteins that accumulate in brain

    Expires Mon Jun 01 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11453870

    Ligase fusion proteins and application thereof

    Expires Mon Sep 22 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11389550

    Nanoparticle, contrast agent for magnetic resonance imaging containing same, and ligand compound

    Expires Mon Jul 14 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11345658

    Compounds and compositions comprising the same for treating hypertension or heart failure

    Expires Mon May 26 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 11020479

    Method for production of solid water particles for homeopathy

    Expires Mon May 27 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10604516

    Compounds for imaging tau proteins that accumulate in the brain

    Expires Mon Mar 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 8646246

    Method of preparing a composition in blister packages

    Expires Mon Feb 06 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is doxylamine succinate?

doxylamine succinate (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Quantum Biopharma. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for doxylamine succinate?

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is a marketed brand name for doxylamine succinate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of doxylamine succinate?

doxylamine succinate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.