Aspiverin

(Dapivirine)

Phase 3Small molecule

IInternational Partnership for Microbicides, Inc.

Dapivirine is used to prevent HIV infection in people at high risk, delivered through a vaginal ring that slowly releases the medication over several weeks.[1] Aspiverin is currently being investigated across 3 indications[3], with its most advanced program in Phase 3.[1]

Aspiverin is one of 93 small molecule programs targeting AIDS. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

AIDSActive, not recruiting

HIV InfectionActive, not recruiting

HIV-1 InfectionActive, not recruiting

AIDSPhase 1

Active, not recruiting

HIV InfectionPhase 3

Active, not recruiting

HIV-1 InfectionPhase 2

Active, not recruiting

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Leukine

Sanofi

Phase 3

2 2

Sunlenca

Gilead

Phase 3

1 3

Aspiverin

IInternational Partnership for Microbicides, Inc.

Phase 3

31 4

Betaseron

PEG-Intron

Megace

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

3 8

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

2 9

Foscavir

NNational Institute of Allergy and Infectious Diseases (NIAID)

Phase 3

1 10

Buprenorphine/naloxone

Astellas

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

11 more indications

Trial1 trial

Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT05416021·124 enrolled

Liver1 trial

A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT01144676·45 enrolled

Tolerance1 trial

Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT01277640·48 enrolled

Single Dose1 trial

PK/PD of Single Dose Dapivirine Vaginal Film

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT01924091·60 enrolled

ESS1 trial

Assessing the Safety of Dapivirine Gel and Film Formulations

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT01548560·60 enrolled

Pregnancy1 trial

Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT03965923·1,104 enrolled

Menopausal Women1 trial

Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women

Completed·IInternational Partnership for Microbicides, Inc.·Phase 2·NCT02010593·96 enrolled

TED1 trial

A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1/2·NCT00799058·128 enrolled

Interaction1 trial

To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT02847286·36 enrolled

HIV Prevention1 trial

Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)

Withdrawn·IInternational Partnership for Microbicides, Inc.·Phase 2·NCT03074786

Unspecified10 trials

An Expanded Safety Study of Dapivirine Gel 4789 in Africa

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1/2·NCT00917904·100 enrolled

An Expanded Safety Study of Dapivirine Gel 4759 in Africa

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1/2·NCT00917891·280 enrolled

A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1/2·NCT00303576·112 enrolled

Show 7 more trials

A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1/2·NCT00309205·36 enrolled

A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa

Withdrawn·IInternational Partnership for Microbicides, Inc.·Phase 1/2·NCT00304668

A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium

Withdrawn·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT01242579

Dapivirine Gel Rectal Safety and PK Study

Withdrawn·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT03044379

Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT00332995·13 enrolled

Expanded Use PK of Dapivirine Vaginal Ring

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT01952561·40 enrolled

A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

Completed·IInternational Partnership for Microbicides, Inc.·Phase 1·NCT00469768·24 enrolled

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Dapivirine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dapivirine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dapivirine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — International Partnership for Microbicides, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: IInternational Partnership for Microbicides, Inc.

Aspiverin

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Women3 trials

Tics3 trials

Safety and Efficacy2 trials

HIV-12 trials

TIA1 trial

Trial1 trial

Liver1 trial

Tolerance1 trial

Single Dose1 trial

ESS1 trial

Pregnancy1 trial

Menopausal Women1 trial

TED1 trial

Interaction1 trial

HIV Prevention1 trial

Unspecified10 trials

References

Drug Info

Quick Facts

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