pirmitegravir (STP0404) / Dong-A - LARVOL DELTA

Design of second-generation pirmitegravir analogues with enhanced resistance profiles | Poster Board #1367 (ACS-Fall 2026) - "Highly potent Integrase Strand Transfer Inhibitors (INSTIs), such as dolutegravir and cabotegravir, are FDA approved first-line therapies. These warrants continued efforts to develop PIR analogues with an enhanced barrier to resistance. This project focuses on the design, synthesis, and optimization of PIR-based analogues to support ALLINI development and HIV-1 therapeutic strategies."

Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial of STP0404 in Adults With HIV-1 Infection (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: ST Pharm Co., Ltd. | N=36 ➔ 25 | Recruiting ➔ Completed

Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

A Clinical Trial of STP0404 in Adults With HIV-1 Infection (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: ST Pharm Co., Ltd. | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Erratum for Dinh et al., "The structural and mechanistic bases for the viral resistance to allosteric HIV-1 integrase inhibitor pirmitegravir". (PubMed, mBio) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial of STP0404 in Adults with HIV-1 Infection (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: ST Pharm Co., Ltd. | Trial completion date: Nov 2024 ➔ Dec 2025 | Trial primary completion date: Oct 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

The structural and mechanistic bases for the viral resistance to allosteric HIV-1 integrase inhibitor pirmitegravir. (PubMed, mBio) - "Here, we have elucidated the structural and mechanistic bases behind the emergence of HIV-1 integrase mutations in infected cells that confer resistance to pirmitegravir. In turn, our findings allowed us to rationally develop an improved ALLINI with substantially enhanced potency against the pirmitegravir-resistant virus."

Journal • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: ST Pharm Co., Ltd. | Trial completion date: May 2024 ➔ Nov 2024 | Trial primary completion date: Apr 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: ST Pharm Co., Ltd. | Phase classification: P2a ➔ P2

Phase classification • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection (clinicaltrials.gov) - P2a | N=36 | Recruiting | Sponsor: ST Pharm Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2024 ➔ Apr 2024

Enrollment open • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection (clinicaltrials.gov) - P2a | N=36 | Not yet recruiting | Sponsor: ST Pharm Co., Ltd.

New P2a trial • Human Immunodeficiency Virus • Infectious Disease • CD4