Drugs / 129Xe
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2022-03-31 | “We have resubmitted the NDA for our 129Xenon drug-device combination product, following extensive discussions with the FDA” polarean.com ↗ |
| Filed | US (FDA) | — | lung imaging | 2020-10-07 | “NDA Submission NDA submission for Polarean’s hyperpolarised 129Xenon gas drug-device diagnostic for lung imaging” polarean.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01697332 | Jan 2013 → Dec 2016 | chronic obstructive pulmonary disease | Brigham and Women's Hospital | Terminated | No outcome recorded Stop: Business |
| Phase 41 trial | ||||||
| Phase 4 | NCT04995562 | May 2020 → May 2027 expected | lung disorder | Children's Hospital Medical Center, Cincinnati | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT04991389 Background | Aug 2019 → Sep 2027 expected | obstructive sleep apnea syndrome | Children's Hospital Medical Center, Cincinnati | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2022-12-28 | Polarean, Inc. | Regulatory FDA Approves Polarean’s XENOVIEW™ (xenon Xe 129 hyperpolarized) polarean.com ↗
Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that the U.S. Food and Drug Administration (“FDA”) has granted approval for its drug device combination product, XENOVIEW. |
| 2022-09-22 | Polarean, Inc. | Regulatory Update on New Drug Application polarean.com ↗ |
| 2022-03-31 | Polarean, Inc. | Regulatory NDA Resubmission polarean.com ↗
We have resubmitted the NDA for our 129Xenon drug-device combination product, following extensive discussions with the FDA regarding the issues that were raised in the CRL. |
| 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. |
| 2020-10-07 | Polarean, Inc. | Regulatory Polarean Announces NDA Submission of 129 Xenon Gas MRI polarean.com ↗
The submission of the NDA follows the Company’s successful completion of two Phase III clinical trials (the “Clinical Trials”) which demonstrated effective measurement of regional lung ventilation. |
| 2020-01-29 | Polarean, Inc. | Results Positive Results Announced from Pivotal Phase III Clinical Trials polarean.com ↗ |
| 2011-08-01 | Xemed LLC | Regulatory Xemed completes regulatory filings with Health Canada xemed.com ↗
Earlier in the summer, Xemed had submitted a “Drug Master File” on MagniXene™ to Health Canada to begin the two-step regulatory filing process. |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-12-28 | Polarean, Inc. | FDA Approves Polarean’s XENOVIEW™ (xenon Xe 129 hyperpolarized) polarean.com ↗ |
| 2022-09-22 | Polarean, Inc. | Update on New Drug Application polarean.com ↗ |
| 2022-03-31 | Polarean, Inc. | NDA Resubmission polarean.com ↗ |
| 2021-10-06 | Polarean, Inc. | Complete Response Letter Received from FDA polarean.com ↗ |
| 2020-10-07 | Polarean, Inc. | Polarean Announces NDA Submission of 129 Xenon Gas MRI polarean.com ↗ |
| 2020-01-29 | Polarean, Inc. | Positive Results Announced from Pivotal Phase III Clinical Trials polarean.com ↗ |
| 2011-08-01 | Xemed LLC | Xemed completes regulatory filings with Health Canada xemed.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 | 129Xe | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04995562 ↗ |
| Modality | Diagnostic / imaging agent | “hyperpolarized 129Xe MRI” NCT01697332 ↗ |
| Route | Inhaled | “will be inhaled by a subject” NCT01697332 ↗ |