Drugs / CC-42344
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05202379 | Feb 2022 → Mar 2023 | influenza | Cocrystal Pharma, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06160531 | Nov 2023 → May 2024 | influenza | Cocrystal Pharma, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2025-05-29 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma’s Investigational Drug Candidate CC-42344 Demonstrates Strong Antiviral Potency Against the 2024 Highly Pathogenic H5N1 Avian Influenza Strain cocrystalpharma.com ↗
The data showed that CC-42344 was highly potent against the H5N1 avian influenza virus (EC50, 0.003 µM), approximately 1,000-fold more potent, compared to a refence compound Tamiflu (EC50, 2.69 µM). |
| 2024-12-31 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma to Extend Phase 2a Influenza Challenge Study with Oral PB2 inhibitor CC-42344 cocrystalpharma.com ↗
While CC-42344 showed a favorable safety and tolerability profile, we’re disappointed by the low infectivity rate of the challenge influenza strain used in this study. |
| 2024-06-20 | Cocrystal Pharma, Inc. | Results New Broad-Spectrum Antiviral Currently in a Phase 2a Clinical Trial in Influenza A may be Effective Against the H5N1 Avian Influenza Strain Identified in Humans Exposed to Infected Dairy Cows cocrystalpharma.com ↗
Cocrystal Pharma, Inc .’s (Nasdaq: COCP) novel, broad-spectrum antiviral CC-42344 inhibits activity in the highly pathogenic avian influenza A (H5N1) PB2 protein recently identified in infected dairy cattle, according to recently completed in vitro studies. |
| 2024-03-19 | Cocrystal Pharma, Inc. | Regulatory Cocrystal Pharma Receives Pre-IND Responses from the FDA on Oral CC-42344 for Treating Influenza A cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA) regarding CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. |
| 2024-01-04 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Provides an Update on the Clinical Development of its Novel, Broad-Spectrum Antiviral Investigational Candidates cocrystalpharma.com ↗ |
| 2023-11-29 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Highlights its Novel Inhaled and Oral Influenza A Antiviral CC-42344 at the World Vaccine Congress West Coast cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces the presentation of favorable data demonstrating activity of its potent broad-spectrum PB2 inhibitor CC-42344 against pandemic and seasonal influenza A strains at the World Vaccine Congress West Coast . |
| 2023-10-31 | Cocrystal Pharma, Inc. | Regulatory Cocrystal Pharma Receives UK MHRA Authorization to Initiate Its Phase 2a Influenza Human Challenge Trial with Oral PB2 Inhibitor CC-42344 cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces receipt of authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial with its broad-spectrum, oral PB2 inhibitor CC-42344 as a potential treatment for pandemic and seasonal influenza A. |
| 2023-05-04 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Presents New Data from its CC-42344 Phase 1 Influenza A Study at the 7th Annual ISIRV Antiviral Group Conference cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces that new data from its CC-42344 Phase 1 influenza A Study was presented today by Sam Lee, Ph.D., President and co-CEO, at the 7 th Annual International Society for Influenza and Other Respiratory Virus Diseases’ (ISIRV) Antiviral Group Conference . |
| 2022-12-19 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Reports Highly Favorable Safety and Tolerability Results from a Phase 1 Study with its Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) announces highly favorable safety and tolerability results for its orally administered replication inhibitor CC- 42344 in its Phase 1 study. |
| 2022-12-01 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Highlights Progress with CC-42344 as a Potential Oral Treatment for Pandemic and Seasonal Influenza A at the World Antiviral Congress 2022 cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that progress with CC-42344 for the treatment of pandemic and seasonal influenza A from its Phase 1 study was presented today at the World Antiviral Congress 2022 underway in San Diego. |
| 2022-11-17 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Announces Favorable Safety Data from the Phase 1 Study with Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) today announced that CC-42344 demonstrated a favorable safety profile in both the single-ascending dose and the multiple-ascending dose portions of the ongoing Phase 1 study. |
| 2022-11-01 | Cocrystal Pharma, Inc. | Regulatory Cocrystal Pharma Granted European Patent Covering Oral Antiviral Candidate CC-42344 in Combination with Another Antiviral Agent for the Treatment of Influenza cocrystalpharma.com ↗
Cocrystal Pharma, Inc. (Nasdaq: COCP) announces it has been granted European patent EP3866778 titled "Combinations Of Inhibitors of Influenza Virus Replication,” which covers the Company’s broad-spectrum oral PB2 inhibitor CC-42344 in combination with approved influenza antiviral drugs including Tamiflu ® , Xofluza ® or Favipiravir. |
| 2022-08-15 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Reports Second Quarter 2022 Financial Results and Provides Updates on its Antiviral Development Programs cocrystalpharma.com ↗
Reported pharmacokinetic (PK) data from the single ascending dose portion of its Phase 1 study with CC-42344 supporting once-daily dosing |
| 2022-07-14 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Reports CC-42344 Pharmacokinetic Data in Influenza A Once-Daily Dosing cocrystalpharma.com ↗
The PK data from single ascending dose portion of the trial mark a major milestone in the development of CC-42344 ’s as our drug holds potential to be administered once a day, less frequently than the leading influenza treatment Tamiflu ® , |
| 2022-04-12 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Reports Favorable Preliminary Data from Phase 1 Initial Cohorts with CC-42344, a Novel, Broad-Spectrum Influenza A antiviral cocrystalpharma.com ↗
Results from the first two single-ascending dose 100 mg and 200 mg cohorts showed a favorable pharmacokinetic profile of CC-42344. |
| 2021-10-06 | Cocrystal Pharma, Inc. | Regulatory Cocrystal Pharma Receives Australian Regulatory Clearance to Initiate Phase 1 Study of CC-42344 for the Treatment of Pandemic and Seasonal Influenza cocrystalpharma.com ↗ |
| 2020-10-19 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Provides Update on Influenza A Program cocrystalpharma.com ↗
Cocrystal’s recent data shows that CC-42344 retained single digit nanomolar potency (EC50 = 0.5 nM) against Xofluza (baloxavir) resistant influenza A strain (H1N1, I38T). |
| 2019-09-03 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Presents Positive Preclinical Data for CC-42344 at the Options X for the Control of Influenza Conference cocrystalpharma.com ↗
Results from the preclinical study demonstrated high resolution X-ray cocrystal structures of CC-42344 and other PB2 inhibitors, and further revealed a channel connected to the high conserved m7GTP binding site. |
| 2018-11-13 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Announces Presentation of Preclinical Characterization Data of CC-42344 at the 6th ISIRV-AVG Conference cocrystalpharma.com ↗ |
All press releases naming this drug 28 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CC-42344 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05202379 ↗ |
| Action | Inhibit | “Influenza A Virus Replication Inhibitor” NCT05202379 ↗ |
| Route | Oral | “single oral dose of the study drug or placebo” NCT05202379 ↗ |