Drugs / BCX9930
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | — | — | “FDA informed the company that it has placed the clinical program for BCX9930 on a partial clinical hold.” biocryst.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04330534 | Mar → Nov 2020 | paroxysmal nocturnal hemoglobinuria | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05741346 | Jan 2023 → Jan 2025 | paroxysmal nocturnal hemoglobinuria | BioCryst Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05162066 | Feb → Sep 2022 | IgA glomerulonephritis, complement 3 glomerulopathy, membranous glomerulonephritis | BioCryst Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05116774 | Dec 2021 → Sep 2023 | paroxysmal nocturnal hemoglobinuria | BioCryst Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05116787 | Oct 2021 → Sep 2023 | paroxysmal nocturnal hemoglobinuria | BioCryst Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04702568 | Dec 2020 → Oct 2023 | paroxysmal nocturnal hemoglobinuria | BioCryst Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2022-08-26 | BioCryst Pharmaceuticals | Results BioCryst Presents Data Demonstrating >99 Percent Suppression of Alternative Pathway Complement Activity with BCX9930 in C3G Patients biocryst.com ↗ |
| 2022-08-04 | BioCryst Pharmaceuticals | Regulatory BioCryst Resumes Enrollment in BCX9930 Clinical Program biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has lifted its partial clinical hold on the BCX9930 program. |
| 2022-08-04 | BioCryst Pharmaceuticals | Regulatory BioCryst Reports Second Quarter 2022 Financial Results and Upcoming Key Milestones biocryst.com ↗
On August 4, 2022, the company announced that the U.S. Food and Drug Administration (FDA) has lifted its partial clinical hold on the BCX9930 program. |
| 2022-04-08 | BioCryst Pharmaceuticals | Results BioCryst Pauses Enrollment in BCX9930 Clinical Trials biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company has paused enrollment in clinical trials with BCX9930 while the company investigates elevated serum creatinine levels seen in some patients. |
| 2021-03-22 | BioCryst Pharmaceuticals | Results BioCryst’s Oral Factor D Inhibitor, BCX9930, Advancing to Pivotal Trials in PNH Following Successful Proof of Concept Trial biocryst.com ↗
Following doses of 400 mg bid or 500 mg bid of oral BCX9930, 100 percent of treatment-naïve patients and 83 percent of C5 inadequate response patients were transfusion-free |
| 2020-12-06 | BioCryst Pharmaceuticals | Results BioCryst’s Oral Factor D Inhibitor (BCX9930) Shows High Potency and Specificity for Alternative Pathway of Complement biocryst.com ↗
In the study, BCX9930 was highly specific for the alternative pathway and, after oral dosing of BCX9930 in primates, alternative pathway activity was completely suppressed. |
| 2020-09-30 | BioCryst Pharmaceuticals | Results BioCryst’s Oral Factor D Inhibitor, BCX9930, Shows Clinical Benefit as Monotherapy Through 400 mg bid in Treatment-naïve PNH Patients biocryst.com ↗
Oral BCX9930 is driving rapid and dose-dependent reductions in key biomarkers, including LDH, and increasing hemoglobin levels in all PNH patients in the trial. |
| 2020-08-31 | BioCryst Pharmaceuticals | Regulatory FDA Grants Orphan Drug Designation for BCX9930 in PNH biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). |
| 2020-08-03 | BioCryst Pharmaceuticals | Regulatory FDA Grants Fast Track Designation for BCX9930 in PNH biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). |
| 2019-10-28 | BioCryst Pharmaceuticals | Results BioCryst Reports Data From Phase 1 Trial of BCX9930 and Announces Plans to Advance Program Into Proof of Concept Study in PNH Patients biocryst.com ↗
BCX9930 was safe and generally well tolerated, and showed rapid, sustained and >95% suppression of the alternative pathway (AP) of the complement system at 100 mg every 12 hours, as measured by the AP Wieslab ® assay. |
All press releases naming this drug 19 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BCX9930 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05116787 ↗ |
| Route | Oral | “BCX9930 capsules for oral administration” NCT04330534 ↗ |