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Valproate bismuth

Generic Name
Valproate bismuth
Drug Type
Small Molecule
Chemical Formula
C24H45BiO6
CAS Number
60364-28-5
Unique Ingredient Identifier
87PTX621FI

Overview

Valproate bismuth is available in Canada in the over-the-counter medication Neo-Laryngobis.

Indication

No indication information available.

Associated Conditions

  • Anginal Pain
  • Gingivostomatitis
  • Laryngitis
  • Pharyngitis
  • Sore Throat
  • Tonsillitis

Research Report

Published: Sep 15, 2025

Comprehensive Analysis of Valproate Bismuth (DB13910)

Executive Summary

Valproate bismuth (DrugBank ID: DB13910) is a small molecule compound chemically defined as bismuth(3+) tris(2-propylpentanoate).[1] It is a salt composed of a trivalent bismuth cation and three valproate anions, the deprotonated form of valproic acid. The primary and sole identified clinical application of this compound is as the active pharmaceutical ingredient (API) in Neo-Laryngobis, an over-the-counter (OTC) medication marketed in Canada for the symptomatic relief of laryngitis, pharyngitis, and other inflammatory conditions of the throat.[2]

This report provides an exhaustive analysis of Valproate bismuth, navigating a profound dichotomy that defines its pharmacological and regulatory profile. The central finding is that the therapeutic utility of Valproate bismuth in its commercial formulation is almost exclusively attributable to the local anti-inflammatory and antimicrobial properties of its bismuth moiety. Evidence suggests a unique pharmacokinetic pathway following rectal administration, whereby the compound is absorbed into the lymphatic system and subsequently delivered to the pharyngeal area via the tonsils and saliva, enabling a targeted topical effect.[5]

This localized mechanism stands in stark contrast to the well-documented, systemic, and potent central nervous system (CNS) effects of its valproate moiety. Valproic acid is a cornerstone therapy for epilepsy, bipolar disorder, and migraine prophylaxis, acting through mechanisms such as GABAergic enhancement and ion channel modulation that are functionally irrelevant to the treatment of laryngitis.[7] For the Neo-Laryngobis formulation, the valproate component appears to serve primarily as a chemical counter-ion, creating a lipophilic salt that facilitates absorption from a suppository base.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/24
Not Applicable
Not yet recruiting
Yongquan Shi
2025/07/16
Not Applicable
Recruiting
Yongquan Shi
2025/05/18
Not Applicable
Recruiting
Zhongshan Hospital (Xiamen), Fudan University
2024/12/12
N/A
Not yet recruiting
Xiuli Zuo
2024/09/19
Phase 4
Recruiting
Xijing Hospital of Digestive Diseases
2024/07/23
Phase 4
Completed
Xijing Hospital of Digestive Diseases
2023/12/13
Phase 4
Completed
Yongquan Shi
2023/06/23
Phase 1
Completed
2023/02/24
Phase 4
Completed
Xijing Hospital of Digestive Diseases
2022/02/11
Phase 4
Completed
Xijing Hospital of Digestive Diseases

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Newton Laboratories, Inc.
55714-2465
ORAL
15 [hp_X] in 1 mL
8/20/2025
Deseret Biologicals, Inc.
43742-1312
ORAL
12 [hp_X] in 1 mL
5/27/2025
Dr. Donna Restivo DC
62185-0062
ORAL
12 [hp_X] in 1 mL
5/23/2025
Newton Laboratories, Inc.
55714-2466
ORAL
15 [hp_X] in 1 g
8/20/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
HOMEODEX 06
distributions biodentcom inc.
02232211
Drops - Oral
5 CH
6/3/1998
NEO-LARYNGOBIS
teva canada limited
00065927
Suppository - Rectal
135 MG
12/31/1950
BISMUTHUM METALLICUM GRANULES 5CH-30CH
dolisos laboratoires s.a.
00767743
Tablet - Oral
4 CH / TAB
12/31/1987
HOMEOPATHIC MEDICINE (S#76)- 30C LIQ
total health centre
02104822
Liquid - Sublingual
30 C / ML
12/31/1994
BISMUTH MET DPS 8D
dolisos laboratoires s.a.
00727857
Drops - Oral
8 X / X
12/31/1987
BISMUTHUM METALLICUM
dolisos canada inc.
02234351
Globules ,  Granules ,  Liquid - Oral
6 X
1/5/1998
NEO LARYNGOBIS ENF
lab bio chimique inc.,division of technilab pharma inc.
00065919
Suppository - Rectal
67.5 MG
12/31/1950
BISMUTUM METALLICUM-INJEEL FORTE LIQ (6D,10D,30D,200D/1.1ML)
02070545
Liquid - Oral
6 D / 1.1 ML
12/31/1994
BISMUTUM METALLICUM-INJEEL LIQ (10D,30D,200D/1.1ML)
02062518
Liquid - Oral
10 D / 1.1 ML
12/31/1994

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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