ASTODRIMER SODIUM

Description
Sources: https://clinicaltrials.gov/ct2/show/NCT01577537 | https://www.ncbi.nlm.nih.gov/pubmed/26495445 | https://clinicaltrials.gov/ct2/show/NCT00740584

Astodrimer, also known as SPL7013, a microbicide developed by Starpharm. This drug has been used in phase III clinical trials for the treatment and prevention of Bacterial Vaginosis. Starpharma conducts a meeting with US FDA related to potential approval of astodrimer in Bacterial vaginosis. In addition, SPL7013, participated in phase II clinical trials against human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2). It is known that astodrimer binds tightly to R5 gp120 in the gp120-CD4 complex, thus preventing the accrual of the requisite number of gp120-CD4 complexes across the virus-cell interface, thereby blocking virus entry.

Approval Year

Conditions

Condition	Modality	Targets	Highest Phase	Product
Bacterial Vaginosis 2 Sources: https://clinicaltrials.gov/ct2/show/NCT01577537	Curative		Phase III 656	Unknown Approved Use Unknown

PubMed

Title	Date	PubMed
SPL7013 gel as a topical microbicide for prevention of vaginal transmission of SHIV89.6P in macaques.	2005 Mar	15795526
SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans.	2011	21935377
The SPL7013 dendrimer destabilizes the HIV-1 gp120-CD4 complex.	2015 Nov 28	26495445

Sample Use Guides

In Vivo Use Guide

1% SPL7013 (ASTODRIMER) vaginal gel, daily for 7 days

Route of Administration: Vaginal

Name

Type

Language

ASTODRIMER SODIUM

Official Name

English

Astodrimer sodium [WHO-DD]

Common Name

English

SPL-7013 SODIUM

Code

English

TETRAHEXACONTASODIUM N2,N6-BIS(N2,N6-BIS(N2,N6-BIS(N2,N6-BIS(N2,N6-BIS((3,6- DISULFONAPHTHALEN-1-YLOXY)ACETYL)-L-LYSYL)-L-LYSYL)-L-LYSYL)-L-LYSYL)- N1-(DIPHENYLMETHYL)-L-LYSINAMIDE

Common Name

English

BRI7013 SODIUM

Code

English

BRI-7013 SODIUM

Code

English

6436

Code

English

ASTODRIMER SODIUM [USAN]

Common Name

English

Code System Code Type Description

SMS_ID

300000021737