Size of symbol reflects the phase of clinical trial. E.g. Phase 3 trial has the largest size. Shape definition ▲ Up-triangle: study first submitted. ◼ Square: study completion(actual/anticipated). ⬤ Circle: result first posted. Color definition ▶ Green: study is ongoing. ▶ Blue: recruitment completed. ▶ Red: study aborted/terminated/withdrawn. ▶ Pink: study in abnormal state.
US FDA submission
Size of symbol reflects the type of submission. E.g. Type 1 drug has the largest size. ◆: Approved. ◆: Tentative Approval.
Drug marketing & current status
Circle bubble denotes new drug marketing. Size is determined by drug type and market(i.e. population) size. E.g. Type 1 drug marketed in US has the largest size. Drug marketed in CA has the smallest size due to small population size. Color definition ⬤ Blue circle: drug marketed (EU,CA), FDA submission approved (US). ⬤ Cyan circle: drug approved (CA), tentative approval (US), received positive opinion (EU) ⬤ Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.
Drug marketing status change
Square bubble denotes marketing status change. Size is determined by drug type and market(i.e. population) size. Color definition ◼ Blue square: change from other status to marketed. ◼ Cyan square: change from other status to tentative status. ◼ Red square: change from other status to abnormal or withdrawn status.
Note: "Year" represents clinical trail start year determined by study first submit date.
Three grouping strategies present the same statistical data from different angles, choose any one you are comfortable with. ⬤ at least one study with latest update posted within 7 days.
⬤ at least one study with latest update posted within 30 days.
⬤ at least one study with latest update posted within 90 days.
Clinical Trials Records
No clinical trial record found matching current filtering criteria
Note: "Year" determined by submission status date.
* Original submissions only. Supplementary records not counted. ⬤ at least one submission within 7 days.
⬤ at least one submission within 30 days.
⬤ at least one submission within 90 days.
US FDA Submission Records
Sponsor
Application Type
Drug Name
Active Ingredient
Submission Code
Submission Type
Submission Status
Status Date
Application Number
Agios Pharms Inc
NDA
Pyrukynd
Mitapivat Sulfate
Type 1
Orig
Approval
2022-02-17
216196
Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "NDA" (case insensitive) to show records with "NDA" (New Drug Applications) tag. ⬤ submission status date within 7 days.
⬤ submission status date within 30 days.
⬤ submission status date within 90 days.
Note: This table contains human and animal drugs regulated by US FDA, and biological products regulated by CBER (Center for Biologics Evaluation and Research).
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "discontinued" (case insensitive) to show discontinued drug products.
For human non-bioproduct, marketing date was set to submission approval date.
Possible marketing statuses: Marketed, Prescription, Over-the-counter, Discontinued, None (Tentative Approval). ⬤ any of (marketing/submission/status change) within 7 days.
⬤ any of (marketing/submission/status change) within 30 days.
⬤ any of (marketing/submission/status change) within 90 days.
No marketed drug found matching current filtering criteria
Note: This table contains human and animal drugs regulated by EMA (European Medicines Agency), and summary of opinion published by EMA based on the CHMP's or CVMP's positive or negative recommendation.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "withdrawn" (case insensitive) to show drugs withdrawn.
Possible marketing statuses: Authorised, Refused, Withdrawn, Summary of Opinion.
Summary of Opinion: published by European Medicines Agency (EMA) based on the CHMP's or CVMP's positive or negative recommendation. Further marketing authorization is partially based on this opinion. ⬤ any of (authorization/withdrawn/opinion/status change) date within 7 days.
⬤ any of (authorization/withdrawn/opinion/status change) date within 30 days.
⬤ any of (authorization/withdrawn/opinion/status change) date within 90 days.
No marketed drug found matching current filtering criteria
Note: This table contains human, animal drugs, radiopharmaceutical and disinfectant regulated by CFIA(Canadian Food Inspection Agency) and Health Canada.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "marketed" (case insensitive) to show drugs marketed.
Possible marketing statuses: Marketed, Approved, Dormant, Cancelled Pre Market, Cancelled Post Market, Cancelled (Safety Issue), Cancelled (Unreturned Annual). ⬤ any of (authorization/status change) date within 7 days.
⬤ any of (authorization/status change) date within 30 days.
⬤ any of (authorization/status change) date within 90 days.