Drugs / Xenon-129
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06012500 | Apr 2022 → Dec 2026 expected | interstitial lung disease | Children's Hospital Medical Center, Cincinnati | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03331302 | Sep 2018 → Jun 2020 overdue | chronic obstructive pulmonary disease | University of Virginia | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02740868 Comparator | Aug 2015 → Dec 2026 expected | asthma, cystic fibrosis | The Hospital for Sick Children | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-09-22 | Polarean, Inc. | Regulatory Update on New Drug Application polarean.com ↗
Polarean Imaging plc (AIM: POLX), the medical -imaging technology company, with a n investigational drug-device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that the U.S. Food and Drug Administration (“FDA”) has requested additional information from Polarean’s xenon-129 gas blend drug manufacturing partner. |
| 2021-10-06 | Polarean, Inc. | Regulatory Complete Response Letter Received from FDA polarean.com ↗
The FDA has determined it is unable to approve the NDA in its present form and has provided a list of issues to be addressed by the Company. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-09-22 | Polarean, Inc. | Update on New Drug Application polarean.com ↗ |
| 2021-10-06 | Polarean, Inc. | Complete Response Letter Received from FDA polarean.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Xenon-129 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03331302 ↗ |
| Modality | Diagnostic / imaging agent | “xenon-129 which is used as a contrast agent for lung imaging” NCT02740868 ↗ |
| Route | Inhaled | “Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging” NCT02740868 ↗ |