RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC + RZ358 (10 mg/kg) or Placebo + SOC + RZ358 (5-10 mg/kg) + SOC

Phase 3Active
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Interest: 34/100
34
Hype Score

Development Stage

Pre-clinical
Phase 1
Phase 2
4
Phase 3
5
Approved
Indication / Disease

Congenital Hyperinsulinism

Conditions

Congenital Hyperinsulinism

Trial Timeline

Jan 11, 2024 → Nov 14, 2027

About RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC + RZ358 (10 mg/kg) or Placebo + SOC + RZ358 (5-10 mg/kg) + SOC

RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC + RZ358 (10 mg/kg) or Placebo + SOC + RZ358 (5-10 mg/kg) + SOC is a phase 3 stage product being developed by Rezolute for Congenital Hyperinsulinism. The current trial status is active. This product is registered under clinical trial identifier NCT06208215. Target conditions include Congenital Hyperinsulinism.

What happened to similar drugs?

4 of 20 similar drugs in Congenital Hyperinsulinism were approved

Approved (4) Terminated (0) Active (16)
🔄turoctocog alfa + turoctocog alfaNovo NordiskPhase 3
🔄turoctocog alfa pegolNovo NordiskPhase 3
🔄nonacog beta pegolNovo NordiskPhase 3
🔄nonacog beta pegolNovo NordiskPhase 3
🔄turoctocog alfa + turoctocog alfaNovo NordiskPhase 3
turoctocog alfaNovo NordiskApproved

Hype Score Breakdown

Clinical
17
Activity
12
Company
5
Novelty
0
Community
0

Clinical Trials (1)

NCT IDPhaseStatus
NCT06208215Phase 3Active

Competing Products

20 competing products in Congenital Hyperinsulinism

See all competitors
ProductCompanyStageHype Score
TideglusibAMO PharmaPre-clinical
20
Tideglusib + PlaceboAMO PharmaPhase 2/3
28
TideglusibAMO PharmaPhase 2/3
35
EDIT-101Editas MedicinePhase 1/2
18
Tildacerfont/PlaceboSpruce BiosciencesPhase 2
17
SPR001Spruce BiosciencesPhase 2
25
SPR001Spruce BiosciencesPhase 2
25
Tildacerfont/PlaceboSpruce BiosciencesPhase 2
17
TildacerfontSpruce BiosciencesPhase 2
17
KW-3357Kyowa KirinPhase 1
29
Pasireotide 0.6Mg Solution for Injection + Saline SolutionNovartisPhase 2
27
Sandostatine LPNovartisPhase 2
35
mycophenolate mofetilRochePhase 1
29
turoctocog alfa + turoctocog alfaNovo NordiskPhase 3
40
catridecacog + recombinant factor XIIINovo NordiskPhase 1
29
activated recombinant human factor VIINovo NordiskPhase 2
35
turoctocog alfa pegolNovo NordiskPhase 3
40
recombinant factor XIIINovo NordiskPre-clinical
26
activated recombinant human factor VII, long acting + activated recombinant human factor VII, long actingNovo NordiskPhase 1
29
Advate® + turoctocog alfaNovo NordiskPhase 1
29