regulatory_id,trial_id,jurisdiction,submission_type,submission_date,review_pathway,review_status,pdufa_action_date,advisory_committee_vote,post_market_requirements,orphan_exclusivity_years,pediatric_study_plan
REG-00001,XS-OD-0001,PMDA,IND,2024-06-02,Priority,Under_Review,,,,,True
REG-00002,XS-OD-0001,PMDA,Pre_Submission,2023-08-10,Standard,Complete_Response,,,,,False
REG-00003,XS-OD-0002,FDA,NDA,2022-02-21,Standard,Withdrawn,2022-12-18,14-3 favorable,,,True
REG-00004,XS-OD-0002,FDA,BLA,2021-12-10,Priority,Under_Review,2022-06-08,,,,True
REG-00005,XS-OD-0002,FDA,MAA,2022-06-02,Accelerated,Under_Review,2023-03-29,,,,True
REG-00006,XS-OD-0003,FDA,NDA,2024-05-26,Accelerated,Approved,2025-03-22,,Annual PSUR/PBRER submission,7.0,True
REG-00007,XS-OD-0003,FDA,BLA,2023-12-10,Priority,Approved,2024-06-07,9-3 favorable,Annual PSUR/PBRER submission,7.0,True
REG-00008,XS-OD-0003,FDA,MAA,2024-08-26,Accelerated,Complete_Response,2025-06-22,9-3 favorable,,,False
REG-00009,XS-OD-0004,EMA,IND,2020-08-03,Standard,Under_Review,,,,,False
REG-00010,XS-OD-0004,EMA,Pre_Submission,2019-07-20,Standard,Under_Review,,,,,False
REG-00011,XS-OD-0005,FDA,IND,2025-09-30,Breakthrough,Approved,2026-03-29,,Pediatric study plan within 2 years,7.0,True
REG-00012,XS-OD-0005,FDA,Pre_Submission,2025-08-26,Standard,Approved,2026-06-22,,REMS with ETASU,7.0,True
REG-00013,XS-OD-0006,PMDA,IND,2022-11-13,Sakigake,Under_Review,,,,,False
REG-00014,XS-OD-0007,EMA,IND,2019-01-20,PRIME,Complete_Response,,,,,False
REG-00015,XS-OD-0007,EMA,Pre_Submission,2019-03-12,Standard,Approved,,,Phase IV registry study required,10.0,False
REG-00016,XS-OD-0008,EMA,IND,2022-01-30,Standard,Submitted,,,,,True
REG-00017,XS-OD-0008,EMA,Pre_Submission,2022-03-02,PRIME,Submitted,,,,,True
REG-00018,XS-OD-0009,FDA,IND,2021-06-04,Breakthrough,Submitted,2021-12-01,,,,True
REG-00019,XS-OD-0009,FDA,Pre_Submission,2020-06-16,Accelerated,Submitted,2021-04-12,,,,False
REG-00020,XS-OD-0010,FDA,NDA,2019-09-20,Priority,Complete_Response,2020-03-18,,,,False
REG-00021,XS-OD-0010,FDA,BLA,2020-02-02,Standard,Approved,2020-11-28,12-2 favorable,Pediatric study plan within 2 years,7.0,True
REG-00022,XS-OD-0010,FDA,MAA,2020-07-28,Accelerated,Rejected,2021-05-24,,,,False
REG-00023,XS-OD-0011,PMDA,Post_Market_Supplement,2025-04-10,Priority,Withdrawn,,,,,False
REG-00024,XS-OD-0012,PMDA,IND,2025-01-09,Priority,Under_Review,,,,,True
REG-00025,XS-OD-0013,FDA,Post_Market_Supplement,2021-02-16,Standard,Complete_Response,2021-12-13,,,,True
REG-00026,XS-OD-0014,FDA,IND,2025-09-06,Priority,Approved,,,Pediatric study plan within 2 years,5.0,True
REG-00027,XS-OD-0015,FDA,Post_Market_Supplement,2025-07-04,Breakthrough,Approved,2025-12-31,,Long-term safety follow-up 5 years,7.0,True
REG-00028,XS-OD-0016,PMDA,IND,2021-06-04,Sakigake,Approved,,,REMS with ETASU,5.0,False
REG-00029,XS-OD-0017,FDA,NDA,2020-09-04,Breakthrough,Under_Review,2021-03-03,8-5 favorable,,,False
REG-00030,XS-OD-0017,FDA,BLA,2021-11-27,Breakthrough,Approved,2022-05-26,,Pediatric study plan within 2 years,7.0,True
REG-00031,XS-OD-0017,FDA,MAA,2020-06-04,Breakthrough,Approved,2020-12-01,,Annual PSUR/PBRER submission,7.0,True
REG-00032,XS-OD-0018,FDA,NDA,2025-04-17,Priority,Under_Review,2025-10-14,7-5 favorable,,,True
REG-00033,XS-OD-0018,FDA,BLA,2025-12-16,Breakthrough,Approved,2026-06-14,8-4 favorable,Annual PSUR/PBRER submission,7.0,True
REG-00034,XS-OD-0018,FDA,MAA,2026-04-07,Breakthrough,Under_Review,2026-10-04,,,,False
REG-00035,XS-OD-0019,PMDA,IND,2020-01-17,Standard,Approved,,,Pediatric study plan within 2 years,5.0,False
REG-00036,XS-OD-0019,PMDA,Pre_Submission,2019-04-29,Priority,Under_Review,,,,,False
REG-00037,XS-OD-0020,PMDA,IND,2025-10-13,Standard,Rejected,,,,,False
REG-00038,XS-OD-0021,FDA,Post_Market_Supplement,2022-01-24,Breakthrough,Under_Review,2022-07-23,,,,False
REG-00039,XS-OD-0022,FDA,IND,2027-09-13,Priority,Under_Review,2028-03-11,,,,True
REG-00040,XS-OD-0023,EMA,IND,2025-03-09,Standard,Approved,,,Annual PSUR/PBRER submission,10.0,False
REG-00041,XS-OD-0024,FDA,IND,2022-08-12,Standard,Submitted,2023-06-08,,,,True
REG-00042,XS-OD-0025,FDA,IND,2026-03-29,Priority,Complete_Response,2026-09-25,,,,True
REG-00043,XS-OD-0026,PMDA,IND,2019-10-20,Sakigake,Under_Review,,,,,True
REG-00044,XS-OD-0027,FDA,NDA,2020-01-12,Priority,Submitted,2020-07-10,,,,False
REG-00045,XS-OD-0027,FDA,BLA,2020-02-01,Accelerated,Submitted,2020-11-27,12-1 favorable,,,False
REG-00046,XS-OD-0027,FDA,MAA,2019-12-02,Standard,Submitted,2020-09-27,9-0 favorable,,,True
REG-00047,XS-OD-0028,EMA,IND,2022-07-07,Accelerated,Under_Review,,,,,False
REG-00048,XS-OD-0028,EMA,Pre_Submission,2023-06-11,Accelerated,Under_Review,,,,,False
REG-00049,XS-OD-0029,FDA,IND,2024-08-11,Accelerated,Under_Review,2025-06-07,,,,True
REG-00050,XS-OD-0030,PMDA,IND,2020-08-13,Priority,Under_Review,,,,,True
REG-00051,XS-OD-0031,FDA,NDA,2020-11-17,Standard,Approved,,,Annual PSUR/PBRER submission,5.0,False
REG-00052,XS-OD-0031,EMA,BLA,2020-04-28,Priority,Submitted,,7-3 favorable,,,False
REG-00053,XS-OD-0031,EMA,MAA,2020-04-30,Standard,Under_Review,,,,,False
REG-00054,XS-OD-0032,FDA,IND,2024-03-23,Priority,Approved,2024-09-19,,Pediatric study plan within 2 years,7.0,False
REG-00055,XS-OD-0032,FDA,Pre_Submission,2024-02-12,Standard,Approved,2024-12-08,,Annual PSUR/PBRER submission,7.0,True
REG-00056,XS-OD-0033,EMA,NDA,2025-04-24,Standard,Approved,,9-3 favorable,Pediatric study plan within 2 years,10.0,False
REG-00057,XS-OD-0033,EMA,BLA,2025-07-01,PRIME,Complete_Response,,9-4 favorable,,,False
REG-00058,XS-OD-0033,EMA,MAA,2027-04-08,Accelerated,Complete_Response,,8-4 favorable,,,True
REG-00059,XS-OD-0034,EMA,NDA,2024-01-16,Accelerated,Approved,,,REMS with ETASU,10.0,True
REG-00060,XS-OD-0034,EMA,BLA,2024-03-15,Standard,Complete_Response,,,,,True
REG-00061,XS-OD-0034,EMA,MAA,2025-07-19,Accelerated,Rejected,,7-4 favorable,,,False
REG-00062,XS-OD-0035,EMA,NDA,2025-06-19,Accelerated,Approved,,,Long-term safety follow-up 5 years,10.0,False
REG-00063,XS-OD-0035,EMA,BLA,2025-05-22,PRIME,Submitted,,6-4 favorable,,,True
REG-00064,XS-OD-0035,EMA,MAA,2025-10-24,PRIME,Approved,,12-5 favorable,Long-term safety follow-up 5 years,10.0,False
REG-00065,XS-OD-0036,FDA,IND,2022-09-30,Accelerated,Approved,2023-07-27,,Phase IV registry study required,7.0,False
REG-00066,XS-OD-0037,PMDA,Post_Market_Supplement,2022-09-07,Priority,Approved,,,Annual PSUR/PBRER submission,5.0,True
REG-00067,XS-OD-0038,FDA,NDA,2026-08-21,Breakthrough,Rejected,2027-02-17,,,,True
REG-00068,XS-OD-0038,FDA,BLA,2025-08-26,Priority,Under_Review,2026-02-22,,,,True
REG-00069,XS-OD-0038,FDA,MAA,2026-09-20,Standard,Submitted,2027-07-17,,,,False
REG-00070,XS-OD-0039,FDA,NDA,2023-08-13,Breakthrough,Submitted,2024-02-09,,,,True
REG-00071,XS-OD-0039,FDA,BLA,2023-10-05,Standard,Under_Review,2024-07-31,,,,True
REG-00072,XS-OD-0039,FDA,MAA,2023-11-18,Standard,Submitted,2024-09-13,9-3 favorable,,,True
REG-00073,XS-OD-0040,PMDA,Post_Market_Supplement,2023-03-27,Standard,Withdrawn,,,,,False
REG-00074,XS-OD-0041,FDA,NDA,2025-05-02,Accelerated,Under_Review,2026-02-26,,,,True
REG-00075,XS-OD-0041,FDA,BLA,2025-09-05,Accelerated,Approved,2026-07-02,,Pediatric study plan within 2 years,7.0,False
REG-00076,XS-OD-0041,FDA,MAA,2025-02-28,Accelerated,Under_Review,2025-12-25,,,,False
REG-00077,XS-OD-0042,FDA,NDA,2022-05-11,Priority,Approved,,,Annual PSUR/PBRER submission,5.0,False
REG-00078,XS-OD-0042,PMDA,BLA,2023-02-05,Standard,Approved,,,Long-term safety follow-up 5 years,5.0,False
REG-00079,XS-OD-0042,FDA,MAA,2022-07-14,Standard,Complete_Response,,,,,True
REG-00080,XS-OD-0043,EMA,IND,2027-10-15,Standard,Under_Review,,,,,False
REG-00081,XS-OD-0043,FDA,Pre_Submission,2025-12-26,Standard,Under_Review,,,,,True
REG-00082,XS-OD-0044,FDA,IND,2024-06-30,Accelerated,Under_Review,2025-04-26,,,,False
REG-00083,XS-OD-0045,FDA,NDA,2021-05-15,Breakthrough,Under_Review,2021-11-11,,,,False
REG-00084,XS-OD-0045,FDA,BLA,2021-12-23,Breakthrough,Under_Review,2022-06-21,8-3 favorable,,,True
REG-00085,XS-OD-0045,FDA,MAA,2022-08-07,Standard,Approved,2023-06-03,6-1 favorable,Phase IV registry study required,7.0,False
REG-00086,XS-OD-0046,FDA,IND,2025-03-24,Accelerated,Approved,2026-01-18,,Long-term safety follow-up 5 years,7.0,True
REG-00087,XS-OD-0046,FDA,Pre_Submission,2024-07-27,Breakthrough,Approved,2025-01-23,,Annual PSUR/PBRER submission,7.0,False
REG-00088,XS-OD-0047,FDA,NDA,2024-01-17,Priority,Approved,2024-07-15,,REMS with ETASU,7.0,True
REG-00089,XS-OD-0047,FDA,BLA,2025-09-20,Priority,Under_Review,2026-03-19,,,,False
REG-00090,XS-OD-0047,FDA,MAA,2023-11-15,Priority,Approved,2024-05-13,6-0 favorable,Pediatric study plan within 2 years,7.0,False
REG-00091,XS-OD-0048,FDA,IND,2020-03-29,Standard,Under_Review,2021-01-23,,,,True
REG-00092,XS-OD-0049,PMDA,NDA,2023-06-21,Priority,Under_Review,,,,,False
REG-00093,XS-OD-0049,FDA,BLA,2023-05-26,Priority,Submitted,,9-4 favorable,,,False
REG-00094,XS-OD-0049,FDA,MAA,2023-05-19,Priority,Under_Review,,,,,False
REG-00095,XS-OD-0050,FDA,IND,2025-01-15,Priority,Complete_Response,2025-07-14,,,,False
REG-00096,XS-OD-0050,FDA,Pre_Submission,2025-01-21,Breakthrough,Under_Review,2025-07-20,,,,False
REG-00097,XS-OD-0050,FDA,Type_B_Meeting,2024-04-11,Accelerated,Withdrawn,2025-02-05,,,,True