Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NDec- decitabine-tetrahydrouridine · 1 trial · 1 indication
measured in g/dL
| Arm | Type | Description |
|---|---|---|
| HU-non-eligible - NDec plus placebo | EXPERIMENTAL | HU-non eligible patients randomised to treatment with NDec on one day and placebo on the other day |
| HU-non-eligible - NDec plus NDec | EXPERIMENTAL | HU-non eligible patients randomised to treatment with NDec on both days |
| HU-non-eligible - Placebo plus placebo | PLACEBO_COMPARATOR | HU-non eligible patients randomised to treatment with placebo on both days |
| HU-active - NDec plus placebo | EXPERIMENTAL | HU-active patients randomised to treatment with NDec on one day and placebo on the other day |
| HU-active - NDec plus NDec | EXPERIMENTAL | HU-active patients randomised to treatment with NDec on both days |
| HU-active - HU | ACTIVE_COMPARATOR | HU-active patients randomised to continue on open-label HU treatment |
| Name | Type | Description |
|---|---|---|
| NDec - oral decitabine-tetrahydrouridine | DRUG | Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight |
| HU - Hydroxyurea | DRUG | Participants will get capsules daily (oral administration) according to local labelling |
| Placebo | DRUG | Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight |
Inclusion Criteria: * Age above or equal to 18 years at the time of signing informed consent * Confirmed diagnosis of SCD (including HbSS, HbSC, HbSβ0 thalassaemia and HbSβ+ thalassaemia or other Sickle Cell disease variants) * 2-10 episodes of documented vaso-occlusive crisis (VOCs) within the las...
| 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 |
NDec (decitabine-tetrahydrouridine) is an investigational small molecule being studied for the treatment of sickle cell disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in adult patients with sickle cell disease.
NDec (decitabine-tetrahydrouridine) is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with sickle cell disease.
NDec (decitabine-tetrahydrouridine) is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities for commercial use. The drug is being studied for the treatment of sickle cell disease in adult patients.
NDec (decitabine-tetrahydrouridine) has one completed Phase 2 clinical trial registered under the identifier NCT05405114. This study investigated how well the drug works in people with sickle cell disease and enrolled 96 participants across multiple countries, including the United States, Canada, and several European and Middle Eastern nations.
NDec is a combination of decitabine and tetrahydrouridine. Decitabine is a chemotherapy agent, while tetrahydrouridine is an enzyme inhibitor that may enhance the activity of decitabine. This combination is being studied specifically for sickle cell disease, whereas decitabine alone is used for other conditions.