Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ITU512 · 1 trial · 1 indication
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Number of participants with dose discontinuation due to AEs
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Number of participants with dose interruptions or reductions of ITU512
Dose intensity of ITU512 is computed as the ratio of actual cumulative dose received and actual duration of exposure
Assessment of fetal hemoglobin expression by measuring fetal hemoglobin (HbF)% by high-performance liquid chromatography (HPLC) assay
| Arm | Type | Description |
|---|---|---|
| Part 1A | EXPERIMENTAL | Part 1A in healthy participants |
| Part 1B | EXPERIMENTAL | Part 1B in healthy participants |
| Part 1C | EXPERIMENTAL | Part 1C in healthy participants |
| Part 2A | EXPERIMENTAL | Part 2A in patients with sickle cell disease |
| Part 2B | EXPERIMENTAL | Part 2B in patients with sickle cell disease |
| Part 2C | EXPERIMENTAL | Optional extension in patients with sickle cell disease |
| Name | Type | Description |
|---|---|---|
| ITU512 | DRUG | ITU512 is an investigational, oral, low molecular weight (LMW) compound. |
| Placebo | DRUG | An inactive substance that looks like and is given the same way as ITU512. The effect(s) of ITU512 will be evaluated against the placebo. Placebos are designed as a control and to have no real effect. |
Key Inclusion Criteria: Part 1 (Healthy participants) * Healthy male participants and female participants of non-childbearing potential between 18-55 years of age * In good health as determined by the investigator's assessment of medical history, physical examination, vital signs, ECG, and laborat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Etavopivat Low dose |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, 20vPCV |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Agios Pharmaceuticals, Inc. | AGIO | 2 | PHASE2 | Mitapivat |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470, Famotidine, Pantoprazole |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
ITU512 is an investigational small molecule being developed for the treatment of Sickle Cell Disease. It is currently in Phase 1 clinical development, with a Phase I/II study evaluating its safety and efficacy in healthy participants and patients with Sickle Cell Disease. The drug is not yet approved and remains under investigation.
ITU512 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase I/II clinical trial of ITU512 in healthy participants and patients with Sickle Cell Disease.
ITU512 is in Phase 1 clinical development. The ongoing study, NCT06546670, is a Phase I/II trial that is currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities for the treatment of Sickle Cell Disease.
ITU512 is being studied in a single active clinical trial, NCT06546670, titled "A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease." This randomized, double-blind, controlled trial is recruiting 161 participants in the United States and Turkey, and includes healthy volunteers.
No alternative names for ITU512 have been reported. The drug is identified solely by its code name ITU512 in clinical trial registrations and is being developed by Novartis AG for Sickle Cell Disease.