Drugs / PUL-042
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03097796 | Dec 2024 → Mar 2026 | disease related to hematopoietic stem cell transplant, hematologic disorder | Pulmotect, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT02566252 | Jul 2015 → Jan 2016 | — | Pulmotect, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06665100 | Jun 2025 → Apr 2027 expected | hematopoietic and lymphoid system neoplasm | Pulmotect, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04312997 | Jun 2020 → Jul 2021 | COVID-19 | Pulmotect, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04313023 | Jun 2020 → Jul 2021 | COVID-19 | Pulmotect, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03794557 | Jan 2019 → Dec 2020 | chronic obstructive pulmonary disease | Pulmotect, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2021-11-30 | Pulmotect, Inc. | Results Pulmotect Provides Results from Two Randomized, Placebo Controlled Phase-2 Trials of PUL-042 Against COVID-19 pulmotect.com ↗
Pulmotect, Inc., a clinical-stage biotechnology company, announced results from the second of two Phase 2 clinical trials undertaken in the United States with the support of the U.S. Department of Defense (DOD) to evaluate PUL-042 against COVID-19. |
| 2021-09-21 | Pulmotect, Inc. | Results Pulmotect Reports Positive Topline Results from Randomized, Placebo Controlled Phase-2 Trial of PUL-042 against COVID-19 pulmotect.com ↗ |
| 2020-05-05 | Pulmotect, Inc. | Regulatory Pulmotect receives FDA approval to commence two Phase-2 trials targeting COVID-19 pulmotect.com ↗
Pulmotect, Inc., a clinical-stage biotechnology company, has received approval from the U.S. Food & Drug Administration (FDA) to initiate two COVID-19 Phase-2 clinical trials of its innate immune stimulating drug PUL-042. |
| 2020-01-27 | Pulmotect, Inc. | Results Pulmotect’s PUL-042 Shows Promising Pre-Clinical Efficacy in Preventing Lethal Coronavirus Infection pulmotect.com ↗
In mouse models, a single inhaled dose of PUL-042 was shown to protect the host from SARS-CoV, and the drug significantly reduced the amount of virus in the lungs after infection with either the SARS-CoV or MERS-CoV viruses. |
| 2016-04-05 | Pulmotect, Inc. | Results Pulmotect Completes Second Clinical Trial, Closes $1.75M Investment, Earns $1M NIH Award pulmotect.com ↗
The second clinical trial characterized a favorable safety profile for administering multiple doses of the drug. |
| 2014-10-10 | Pulmotect, Inc. | Results Pulmotect Completes Clinical Testing, Receives CPRIT Funding for Continued Development pulmotect.com ↗
The study results support further development of PUL-042 with doses at and above the expected therapeutic dose showing a favorable safety profile. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-11-30 | Pulmotect, Inc. | Pulmotect Provides Results from Two Randomized, Placebo Controlled Phase-2 Trials of PUL-042 Against COVID-19 pulmotect.com ↗ |
| 2021-09-21 | Pulmotect, Inc. | Pulmotect Reports Positive Topline Results from Randomized, Placebo Controlled Phase-2 Trial of PUL-042 against COVID-19 pulmotect.com ↗ |
| 2020-05-05 | Pulmotect, Inc. | Pulmotect receives FDA approval to commence two Phase-2 trials targeting COVID-19 pulmotect.com ↗ |
| 2020-01-27 | Pulmotect, Inc. | Pulmotect’s PUL-042 Shows Promising Pre-Clinical Efficacy in Preventing Lethal Coronavirus Infection pulmotect.com ↗ |
| 2016-04-05 | Pulmotect, Inc. | Pulmotect Completes Second Clinical Trial, Closes $1.75M Investment, Earns $1M NIH Award pulmotect.com ↗ |
| 2014-10-10 | Pulmotect, Inc. | Pulmotect Completes Clinical Testing, Receives CPRIT Funding for Continued Development pulmotect.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PUL 042 | “The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung...” NCT06665100 ↗ |
| Modality | Oligonucleotide (other) | “20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution” NCT04313023 ↗ |
| Route | Inhaled | “PUL-042 Inhalation Solution” NCT02566252 ↗ |