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
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.
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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