buloxibutid (C21) / Vicore Pharma, Nippon Shinyaku - LARVOL DELTA

ASPIRE-IPF, a global, double-blind, randomized, placebo-controlled Phase 2b trial of buloxibutid, an angiotensin II type 2 receptor agonist, in idiopathic pulmonary fibrosis: trial design and patient characteristics (ERS 2026) - P2 | "Background therapy with nintedanib or nerandomilast is permitted... ASPIRE-IPF is one of the largest Phase 2b studies in IPF to date that aims to investigate the efficacy and safety of buloxibutid in IPF. Baseline data shows inclusion of a representative cohort of IPF participants."

Clinical • P2b data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Buloxibutid (C21) activates the angiotensin II type 2 receptor in alveolar epithelial type II cells, increasing MMP‑13 associated with fibrosis resolution in idiopathic pulmonary fibrosis (ERS 2026) - "Conclusions The results indcate that AEC2 cells are a major source of pulmonary MMP 13 and that AT2R activation may support their viability. The buloxibutid associated increase in plasma MMP 13 may reflect AEC2 mediated activity promoting resolution of fibrosis in IPF."

Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • MMP13 • SFTPC

Vicore Pharma to Present at the European Respiratory Society Congress 2026 (ACCESS Newswire) - "Vicore will present new data on the design and baseline characteristics of patients enrolled in the global Phase 2b ASPIRE trial in buloxibutid, the company's lead program in idiopathic pulmonary fibrosis (IPF), along with translational findings on AT2 receptor activation in alveolar epithelial type II cells and its association with MMP-13, a collagenase linked to fibrosis resolution."

Clinical protocol • Preclinical • Idiopathic Pulmonary Fibrosis

Significant events during the second quarter (Vicore Pharma Press Release) - "In April, Vicore completed patient recruitment in the Phase 2b ASPIRE trial evaluating buloxibutid in idiopathic pulmonary fibrosis (IPF), enrolling more than 360 patients across over 100 sites in 14 countries. Recruitment was completed ahead of schedule, positioning the company to report topline results in mid-2027."

Enrollment status • P2b data • Idiopathic Pulmonary Fibrosis

Beneficial effects of the AT2 receptor agonist buloxibutid (C21) against acute alveolar epithelial cell inflammation during antiviral responses. (PubMed, ERJ Open Res) - "Gene set enrichment analysis revealed that buloxibutid caused a significant suppression of polyinosinic:polycytidylic acid-induced proinflammatory responses, whereas it was without effect on the expression of antiviral genes. Our findings suggest that buloxibutid may have therapeutic potential for treatment of respiratory viral pneumonias by limiting excessive proinflammatory responses that have the potential to lead to a cytokine storm, while maintaining a protective antiviral response."

Journal • Infectious Disease • Inflammation • Pneumonia • Respiratory Diseases

VP-C21-016: A randomised, open-label, single-centre, drug-drug-interaction trial to evaluate the impact of carboxylesterase 2 (CES2)- and CYP3A4-inhibition on the pharmacokinetics of buloxibutid in healthy volunteers (clinicaltrialsregister.eu) - P1 | N=24 | Recruiting | Sponsor: Vicore Pharma AB | Not yet recruiting ➔ Recruiting

Enrollment open • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Buloxibutid: Protection of patents related to dosage form and method-of-use in US/EU until 2042 (Vicore Pharma) - Corporate Presentation

Patent • Idiopathic Pulmonary Fibrosis

New high affinity AT2 receptor ligands comprising a 2-methyl substituted phenylthiophene scaffold. (PubMed, Bioorg Med Chem) - "The most efficient ligands in the series, compounds 10 and 12, with Ki values of 1.9 and 0.97 nM, respectively, demonstrated >1000-fold selectivity over the the AT1 receptor and showed fair stability in human liver microsomes and human hepatocytes, but not in mouse liver microsomes. A tentative binding mode of inhibitor 12 was proposed after docking calculations."

Journal

VP-C21-011: A trial to evaluate efficacy and safety of buloxibutid in people with idiopathic pulmonary fibrosis (clinicaltrialsregister.eu) - P1/2 | N=93 | Active, not recruiting | Sponsor: Vicore Pharma AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Vicore Pharma Announces Presentations at the 2026 American Thoracic Society International Conference (ACCESS Newswire) - "The abstracts include analyses from the completed Phase 2a AIR trial in idiopathic pulmonary fibrosis (IPF), as well as translational research exploring the biological pathways associated with angiotensin II type 2 (AT2) receptor activation."

P2a data • Idiopathic Pulmonary Fibrosis

VP-C21-016: A randomised, open-label, single-centre, drug-drug-interaction trial to evaluate the impact of carboxylesterase 2 (CES2)- and CYP3A4-inhibition on the pharmacokinetics of buloxibutid in healthy volunteers (clinicaltrialsregister.eu) - P1 | N=24 | Not yet recruiting | Sponsor: Vicore Pharma AB

New P1 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Vicore Pharma Completes Enrollment in the Phase 2b ASPIRE Trial of Buloxibutid in Idiopathic Pulmonary Fibrosis (ACCESS Newswire) - "Vicore expects to report topline results from ASPIRE in mid-2027..."

Enrollment closed • P2b data • Idiopathic Pulmonary Fibrosis

ASPIRE: A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: Vicore Pharma AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Microvascular Normalization and Fibrosis Regression by The Angiotensin II Type 2 Receptor Agonist Buloxibutid in Pulmonary Hypertension Associated With Interstitial Lung Disease (ATS 2026) - No abstract available

Cardiovascular • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Buloxibutid's Efficacy in the Phase 2a Air IPF Trial: Comparative Analysis of Baseline Characteristics of Indian Versus World Cohorts (ATS 2026) - No abstract available

Clinical • P2a data • Idiopathic Pulmonary Fibrosis

Buloxibutid Stabilizes and Improves Lung Function in Idiopathic Pulmonary Fibrosis and Elevates Plasma Mmp-13, Linking AT2 Receptor Activation in Alveolar Epithelial Type 2 Cells to Resolution of Fibrosis (ATS 2026) - No abstract available

Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • MMP13

Investigational insights into the potential of angiotensin type II receptor agonists as therapeutics for idiopathic pulmonary fibrosis. (PubMed, Expert Opin Investig Drugs) - "Current standard-of-care for idiopathic pulmonary fibrosis is limited to nintedanib and pirfenidone, which only slow the progressive loss of lung function and have significant adverse effects that are intolerable to many patients. Ongoing development of novel, more highly selective AT2R agonists may deliver the same clinical benefit as C21 with reduced off-target effects. The AT2R drug class offers great promise as novel therapeutics, potentially extending beyond IPF to other inflammatory and fibrotic lung diseases."

Journal • Review • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases

Protective effects of buloxibutid and empagliflozin on hypertension-induced cardiac and vascular injury in rats. (PubMed, J Mol Histol) - "This study aims to see the individual and combined effects of Angiotensin II type 2 (AT2) receptor agonist buloxibutid (also known as Compound 21 or C21) and sodium-glucose co-transporter-2 (SGLT-2) inhibitor empagliflozin (EMPA) on effects of hypertension (HT), which is common today, on the heart, and vascular tissue. In the HT group, dilatation in some parts and irregularities in elastic lamellae were observed. It was observed that the treated groups were similar to group C. When considering the individual and combined effects of C21 and EMPA, positive results on heart and vascular tissue were observed by hemodynamic, biochemical and histopathological analyses."

Journal • Preclinical • Cardiovascular • Hypertension • CAT

A Druggable Tumor Suppressor and Leukemic Stem Cell Marker. (PubMed, bioRxiv) - "We tested buloxibutid (C21), a small-molecule AT2R agonist currently in phase II trials for idiopathic pulmonary fibrosis, in AML PDX models derived from 20 de novo and 6 relapsed AML samples. C21 significantly inhibited AML progression and enhanced the efficacy of chemotherapy, particularly in relapsed AML models."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Idiopathic Pulmonary Fibrosis • Immunology • Leukemia • Oncology • Pulmonary Disease • Respiratory Diseases • CD34 • CTNNB1 • KIT

ASPIRE: A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: Vicore Pharma AB | Trial completion date: Mar 2027 ➔ Jun 2027

Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

ASPIRE: A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: Vicore Pharma AB | N=270 ➔ 360

Enrollment change • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

ASPIRE is on track to complete enrollment in the first half of 2026… (ACCESS Newswire)

Trial status • Idiopathic Pulmonary Fibrosis

Buloxibutid Receives Orphan Drug Designation in Japan for the Treatment of Idiopathic Pulmonary Fibrosis (ACCESS Newswire) - "Buloxibutid is being evaluated in the global Phase 2b ASPIRE trial for the treatment of IPF."

Orphan drug • Idiopathic Pulmonary Fibrosis

Vicore will present new findings from the 36-week Phase 2a AIR trial of buloxibutid in idiopathic pulmonary fibrosis (IPF), including a synthetic control arm (SCA) analysi (ACCESS Newswire) - "Among patients with comparable baseline characteristics, buloxibutid showed statistically significant improvement in forced vital capacity (FVC) at 36 weeks relative to both baseline and synthetic control, confirming the disease-modifying signal observed in the AIR trial."

P2a data • Idiopathic Pulmonary Fibrosis

Late Breaking Abstract - Synthetic Arm Generation Utilizing Real-World Patient Data Demonstrates Treatment Effect in the Phase 2a AIR trial of Buloxibutid in IPF (ERS 2025) - "We have demonstrated a statistically significant treatment effect for 100mg BID of buloxibutid at 36 weeks, utilizing MCCV-generated synthetic control arms with matched clinical variables. This is the first use of synthetically generated control arms for efficacy testing in IPF."

Clinical • Late-breaking abstract • P2a data • Real-world • Real-world evidence • Idiopathic Pulmonary Fibrosis • Immunology