Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Drug: Atrasentan
Atrasentan · 3 trials · 6 indications
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 36. (non-SGLT2i stratum)
Type, incidence, severity, seriousness, and relatedness of TEAEs.
Incidence, severity, seriousness, and relatedness AESIs.
Type, incidence, severity, seriousness, and relatedness of TEAEs
Incidence, severity, seriousness, and relatedness AESIs.
Change in proteinuria from Baseline to Week 12 across both periods between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12
The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12
The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24
| Arm | Type | Description |
|---|---|---|
| Atrasentan | EXPERIMENTAL | Double-blind Period: Once daily oral administration of 0.75 mg atrasentan for 132 weeks. Open-label Extension Period: Once daily oral administration of 0.75 mg atrasentan for 48 weeks after completion of 132 weeks on atrasentan or placebo. Substudy period: Once daily oral administration of 0.75 mg atrasentan + zigakibart for 48 weeks after completion of OL extension period |
| Placebo | PLACEBO_COMPARATOR | Double-blind Period: Once daily oral administration of placebo for 132 weeks |
| Sequence Atrasentan/Placebo | EXPERIMENTAL | Once daily oral administration of 0.75 mg atrasentan for 12 weeks (Period A) followed by once daily oral administration of placebo for 24 weeks (Period B) |
| Sequence Placebo/Atrasentan | EXPERIMENTAL | Once daily oral administration of placebo for 12 weeks (Period B) followed by once daily oral administration of 0.75 mg atrasentan for 24 weeks (Period A) |
| Atrasentan 0.75 mg | EXPERIMENTAL | Once daily oral administration of 0.75 mg atrasentan |
| Atrasentan 1.5 mg | EXPERIMENTAL | Once daily oral administration 1.5 mg atrasentan (FSGS cohorts only) |
| Name | Type | Description |
|---|---|---|
| Atrasentan | DRUG | Film-coated tablet |
| Placebo | DRUG | Film-coated tablet |
| Zigakibart | DRUG | pre-filled syringes with needle safety device |
Inclusion Criteria: Double-Blind period: * Biopsy-proven IgA nephropathy. * Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor th...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 10 | PHASE3 | BION-1301 |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Travere Therapeutics, Inc. | TVTX | 2 | PHASE3 | sparsentan, irbesartan, Dapagliflozin |
| Biogen Inc. | BIIB | 1 | PHASE3 | Felzartamab |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Vertex Pharmaceuticals Incorporated | VRTX | 2 | PHASE3 | Povetacicept |
| Biohaven Ltd. | BHVN | 1 | PHASE1 | BHV-1400 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-097 |
Atrasentan is an investigational small molecule being developed for the treatment of IgA Nephropathy, a kidney disease. It is currently in Phase 3 clinical trials for this condition. The drug is being studied to assess its effects on patients with this disease, with trials conducted across multiple countries.
Atrasentan is a small molecule that targets the endothelin A receptor. This receptor is involved in various physiological processes, and its blockade is being investigated as a potential therapeutic approach for IgA Nephropathy. The drug's mechanism of action is being evaluated in clinical trials to determine its efficacy and safety.
Atrasentan is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy in patients with IgA Nephropathy. The company is listed on the stock exchange under the ticker symbol NVS.
Atrasentan is currently in Phase 3 clinical development for IgA Nephropathy. This phase involves large-scale studies to confirm the drug's effectiveness, monitor side effects, and compare it with standard treatments. The drug is investigational and has not yet been approved by regulatory authorities.
Atrasentan is being studied in several clinical trials. The Phase 3 trial NCT04573478 is active but not recruiting, with 404 participants. A Phase 2 trial NCT04573920 is also active, enrolling 103 patients with proteinuric glomerular diseases. Additionally, a completed Phase 2 crossover study NCT05834738 involved 54 subjects with IgA Nephropathy.
Atrasentan is also known simply as Atrasentan, with no alternative names provided. It is a small molecule drug being investigated for IgA Nephropathy. The drug is being developed by Novartis AG and is currently in Phase 3 clinical trials.