노바티스

주관 임상 단계 분포

• 규제승인2026-07-17

  노바티스 파브할타, IgA신병증 치료제로 FDA 정식 승인 전환

  미국 FDA가 노바티스의 파브할타(Fabhalta)에 대해 부여했던 가속승인을 정식 승인으로 전환했다. 이번 승인은 면역글로불린 A 신병증(IgAN) 성인 환자를 대상으로 한다. 파브할타는 질병 진행 위험이 있는 환자에서 신장 기능 저하 속도를 늦추는 용도로 승인됐다. 기사에는 구체적인 임상 수치나 승인 날짜는 제시되지 않았다.

  Fierce Pharma ↗

FDA 승인

• 2025-09-30

  RHAPSIDO

  REMIBRUTINIB

  NDA218436
• 2025-04-02

  VANRAFIA

  ATRASENTAN HYDROCHLORIDE

  NDA219208
• 2024-04-24

  VIJOICE

  ALPELISIB

  NDA218466
• 2024-04-12

  ENTRESTO SPRINKLE

  SACUBITRIL

  NDA218591
• 2023-12-05

  FABHALTA

  IPTACOPAN HYDROCHLORIDE

  NDA218276
• 2023-03-16

  TAFINLAR

  DABRAFENIB MESYLATE

  NDA217514
• 2023-03-16

  MEKINIST

  TRAMETINIB

  NDA217513
• 2022-04-05

  VIJOICE

  ALPELISIB

  NDA215039
• 2022-03-23

  PLUVICTO

  LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

  NDA215833
• 2022-03-23

  LOCAMETZ

  GALLIUM GA-68 GOZETOTIDE

  NDA215841

진행 중인 임상

• 2상모집 예정· Primary Immune Thrombocytopenia (ITP)

  A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.

  NCT07660172
• 2상모집 예정· PIK3CA-Related Overgrowth Spectrum (PROS)

  Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.

  NCT07679269
• 해당없음모집 예정협력· Referral and Consultation

  Optimizing Referral Pathways for Patients With Hematuria and Moderate-Severe Proteinuria

  NCT07431931
• 단계 미표기모집 예정· Hidradenitis Suppurativa

  A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients

  NCT07690319
• 1상모집 예정협력· Recurrent Diffuse Large B-Cell Lymphoma

  Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell Lymphoma

  NCT07676877
• 3상모집 예정· Acute Coronary Syndrome (ACS)

  Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL

  NCT07625306
• 3상모집 중· Berger Disease

  Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN

  NCT07498335
• 단계 미표기모집 예정· Complement 3 Glomerulopathy

  A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain

  NCT07598448
• 3상모집 예정· Chronic Pruritus of Unknown Origin

  A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

  NCT07700056
• 단계 미표기모집 예정· Metastatic Prostate Cancer

  PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan

  NCT07484269
• 1/2상모집 예정· Acute Lymphoblastic Leukemia

  Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

  NCT07387926
• 2상모집 중· Papulopustular Rosacea

  A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

  NCT07681271
• 3상모집 중· Sjögren´s Disease

  Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden

  NCT07621809
• 단계 미표기모집 예정· Plaque Psoriasis

  A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

  NCT07683065
• 단계 미표기모집 예정· Chronic Spontaneous Urticaria

  Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)

  NCT07642557
• 3상모집 중· Hidradenitis Suppurativa

  An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

  NCT07665437
• 2상모집 예정협력· High-Risk Localized Prostate Cancer

  PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT

  NCT07550517
• 1/2상모집 예정협력· HER2+ Metastatic Breast Cancer

  Asciminib in HER2+ Breast Cancer Brain Metastases

  NCT07136428
• 1상모집 예정협력· Large-cell Lymphoma

  CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)

  NCT07443137
• 4상모집 예정· Spinal Muscular Atrophy

  ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)

  NCT07448610