Drugs / WP1122
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05195723 | May → Oct 2022 | — | Moleculin Biotech, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05365321 | Dec 2022 → Feb 2023 | COVID-19, adult acute respiratory distress syndrome | Andrei Carvalho Sposito | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2022-12-07 | Moleculin Biotech, Inc. | Regulatory Moleculin Granted FDA Fast Track Designation of WP1122 for the Treatment of Glioblastoma Multiforme moleculin.com ↗ |
| 2022-10-14 | Moleculin Biotech, Inc. | Results Moleculin Provides Update on Second Multiple Ascending Dose (MAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK moleculin.com ↗
In conjunction with the study safety review committee, the Company stopped the second MAD cohort when 2 subjects experienced adverse events that, although asymptomatic, met the stoppage criteria in the protocol. |
| 2022-09-06 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives FDA Orphan Drug Designation of WP1122 for the Treatment of Glioblastoma Multiforme moleculin.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation of WP1122 for the treatment of Glioblastoma Multiforme (“GBM”). |
| 2022-08-19 | Moleculin Biotech, Inc. | Results Moleculin Announces Completion of Third Single Ascending Dose (SAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK moleculin.com ↗ |
| 2022-07-08 | Moleculin Biotech, Inc. | Results Moleculin Announces Completion of Second Single Ascending Dose (SAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK moleculin.com ↗ |
| 2022-06-16 | Moleculin Biotech, Inc. | Results Moleculin Announces Completion of First Single Ascending Dose (SAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK moleculin.com ↗ |
| 2022-05-10 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives Approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for Protocol Amendment to Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19 moleculin.com ↗ |
| 2021-12-01 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives FDA Allowance to Begin a Phase 1 Study of WP1122 for the Treatment of Glioblastoma Multiforme moleculin.com ↗
today announced that the US Food and Drug Administration (FDA) is allowing the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM) to go forward. |
| 2021-10-19 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives Authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to Commence Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19 moleculin.com ↗ |
| 2020-07-23 | WPD Pharmaceuticals Sp. z o.o. | Results WPD Pharmaceuticals Licensor Announces New Independent In Vitro Testing Confirms Antiviral Activity of WP1122 in Coronavirus wpdpharmaceuticals.com ↗
Second round of independent laboratory testing confirmed the antiviral activity of WP1122 against coronavirus |
| 2020-07-21 | Moleculin Biotech, Inc. | Results Moleculin Announces New Independent In Vitro Testing Confirms Antiviral Activity of WP1122 in Coronavirus moleculin.com ↗ |
| 2020-06-22 | WPD Pharmaceuticals Sp. z o.o. | Results WPD Pharmaceuticals Licensor Announces Confirmatory in Vitro Analysis of WP1122 wpdpharmaceuticals.com ↗
the results of this repeated round of in vitro testing received by Moleculin on June 1, 2020, confirm that WP1122 has an antiviral effect on Human Coronavirus 229E |
| 2020-06-16 | Moleculin Biotech, Inc. | Results Moleculin Announces Confirmatory In Vitro Analysis of WP1122 moleculin.com ↗ |
| 2020-05-27 | Moleculin Biotech, Inc. | Regulatory Moleculin Provides Update on Coronavirus Drug Development moleculin.com ↗
the US Food and Drug Administration (“FDA”) has granted the Company’s request for a Pre-IND Meeting |
| 2020-04-16 | WPD Pharmaceuticals Sp. z o.o. | Results WPD Pharmaceuticals’ License Partner, Moleculin Biotech to Host Conference Call to Discuss COVID-19 Potential in WP1122 Drug Candidate wpdpharmaceuticals.com ↗ |
| 2020-04-09 | WPD Pharmaceuticals Sp. z o.o. | Results WPD Pharmaceuticals Reports Active Compound in Licensed Drug Candidate Reduces Coronavirus Replication in Vitro by 100% wpdpharmaceuticals.com ↗
The authors reported that inhibiting glycolysis with non-toxic concentrations of 2-DG completely prevented SARS -CoV–2 replication in Caco–2 cells. |
| 2020-03-20 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces Patent Filing to Cover New Coronavirus Drug Candidate moleculin.com ↗
today announced that a new patent application has been filed covering the use of WP1122 and its analogs as therapies to limit the ability of coronavirus and other viruses to replicate. |
| 2018-10-10 | Moleculin Biotech, Inc. | Results Moleculin Announces New Data Discovery Confirming Significant Increase in Potential to Starve Cancerous Tumors moleculin.com ↗
We believe that we have discovered new data during our IND-enabling research with animals that confirms a highly beneficial metabolism of WP1122 and significant organ accumulation of the inhibitor of glycolysis in the brain and also in the pancreas. |
All press releases naming this drug 31 releases
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 | WP1122 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05195723 ↗ |
| Modality | Small molecule | — CHEMBL5095263 ↗ |
| Route | Oral | “administered as an oral (PO) solution” NCT05195723 ↗ |