MedPath

Sodium stibogluconate

Generic Name
Sodium stibogluconate
Drug Type
Small Molecule
Chemical Formula
C12H35Na3O26Sb2
CAS Number
16037-91-5
Unique Ingredient Identifier
APJ6285Y89

Overview

Sodium stibogluconate is a medicine used to treat leishmaniasis and is only available for administration by injection. It belongs to the class of medicines known as the pentavalent antimonials. Sodium stibogluconate is sold in the UK as Pentostam (manufactured by GlaxoSmithKline). Widespread resistance has limited the utility of sodium stibogluconate, and in many parts of the world, amphotericin or miltefosine are used instead. It is also being investigated as an anti-tumor agent.

Indication

For the treatment of various types of a protozoal infection called leishmaniasis, which may result from sandfly bites in tropical and temperate parts of the world. Also investigated for use/treatment in cancer/tumors (unspecified) and solid tumors.

Associated Conditions

  • Leishmaniasis
  • Mucocutaneous Leishmaniasis
  • Visceral Leishmaniasis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2023/07/24
Phase 2
Active, not recruiting
Drugs for Neglected Diseases
2021/05/28
Phase 2
UNKNOWN
First Affiliated Hospital of Jinan University
2017/04/26
Phase 3
Completed
Drugs for Neglected Diseases
2012/08/09
Phase 4
Completed
Sarder Patel Medical College
2009/11/11
Phase 2
Completed
Access to Advanced Health Institute (AAHI)
2009/11/06
Phase 1
Terminated
2009/10/16
Phase 2
Completed
Waisenmedizin e. V. Promoting Access to Essential Medicine
2008/03/05
Phase 1
Completed
2007/07/11
Phase 1
Completed
2006/04/06
Phase 1
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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

HSA Drug Approvals

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Approval Number
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Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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

PPB Drug Approvals

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

TGA Drug Approvals

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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
No Health Canada approvals found for this drug.

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
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Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
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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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