Drugs / Opelconazole
Opelconazole
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02715570 | Oct 2017 → Apr 2018 | aspergillosis | Pulmocide Ltd | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05037851 | Nov 2021 → Oct 2023 | aspergillosis | Pulmocide Ltd | Completed | No outcome recorded |
| Phase 2 | NCT03905447 | Sep 2019 → Jun 2020 | aspergillosis, disease related to solid organ transplantation | Pulmocide Ltd | Terminated | No outcome recorded |
| Phase 2 | NCT03870841 | Apr 2019 → Jun 2020 | aspergillosis, cystic fibrosis | Pulmocide Ltd | Terminated | No outcome recorded |
| Phase 2 | NCT03745196 | Nov 2018 → Jun 2020 | aspergillosis, asthma, bronchiectasis, candidiasis | Pulmocide Ltd | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05238116 | Jun 2022 → Dec 2025 | — | Pulmocide Ltd | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-01-07 | Pulmocide Ltd | Results Pulmocide Announces Termination of Opera-T Phase 3 Study with Opelconazole pulmocide.com ↗
The analysis showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm. |
| 2024-04-15 | Pulmocide Ltd | Results Pulmocide Announces Successful Results from the OPERA-S Study: a Phase 2 Safety Study with Inhaled Opelconazole pulmocide.com ↗
In this study, opelconazole was generally well tolerated with a low incidence of drug-related adverse events (AEs) and a low incidence of treatment-limiting respiratory AEs. |
| 2023-10-16 | Pulmocide Ltd | Results Pulmocide Announces New Clinical Data Confirming Low Potential for Drug-Drug Interactions with Inhaled Opelconazole pulmocide.com ↗
These data fall below the threshold stipulated by the FDA Guidance on Clinical Drug Interaction Studies (geometric mean ratio of at least 1.25), suggesting opelconazole poses a negligible risk for an inhibitory effect. |
| 2021-09-16 | Pulmocide Ltd | Regulatory Pulmocide’s lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA pulmocide.com ↗
Pulmocide Ltd. (“the Company”), a late-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for patients with severe pulmonary diseases, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug, Fast Track and Qualified Infectious Disease Product designations for opelconazole (PC945) for the treatment of invasive pulmonary aspergillosis (IPA). |
| 2021-03-11 | Pulmocide Ltd | Results Pulmocide announces publication of clinical data in two peer-reviewed publications highlighting potential of PC945, a novel inhaled antifungal drug candidate, in lung infections pulmocide.com ↗
The paper, entitled Successful salvage therapy for fungal bronchial anastomotic infection after lung transplantation with an inhaled triazole anti-fungal PC945 , describes the rapid and complete resolution of the infection in both patients after nebulized PC945 was commenced. |
| 2020-03-02 | Pulmocide Ltd | Results Pulmocide announces four presentations on PC945 at the 9th Advances Against Aspergillosis and Mucormycosis conference in Lugano, Switzerland, 27 February – 1 March, 2020 pulmocide.com ↗
These presentations included descriptions of PC945 anti-fungal synergy with systemic echinocadnin in a preclinical model (poster 33) , effects of PC945 on fungal load in mouth wash from healthy subjects (poster 69), accumulation of PC945 in the lungs of neutropenic, immunocompromised mice (poster 68), and the impact of PC945 on the cell wall integrity of A.fumigatus (poster 34 and oral presentation). |
All press releases naming this drug 8 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Opelconazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05037851 ↗ |
| Known as | Opelconazole(inn) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650362 ↗ |
| Known as | PC945 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03905447 ↗ |
| Modality | Small molecule | — CHEMBL4650362 ↗ |
| Route | Inhaled | “Inhaled Doses of PC945” NCT02715570 ↗ |