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Also known as NDec - oral decitabine-tetrahydrouridine
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...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 6 | PHASE3 | Etavopivat |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab, OTQ923, ITU512 |
| Agios Pharmaceuticals, Inc. | AGIO | 3 | PHASE3 | Mitapivat, Tebapivat |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, rilzabrutinib |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE3 | L-Citrulline |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470 |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
NDec-decithabine-tetrahydrouridine is an investigational oral small molecule being studied for the treatment of sickle cell disease in adults. It was evaluated in a Phase 2 clinical trial that enrolled 96 participants aged 18 years and older across the United States, Canada, Europe, the Middle East, India, and South Africa.
NDec-decithabine-tetrahydrouridine is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program evaluating this oral small molecule in sickle cell disease.
NDec-decithabine-tetrahydrouridine is in Phase 2 development for sickle cell disease. The Phase 2 study has been completed, and the drug remains investigational rather than approved for commercial use.
NDec-decithabine-tetrahydrouridine was evaluated in the Phase 2 trial NCT05405114, titled a research study investigating how well NDec works in people with sickle cell disease. The trial enrolled 96 adults, was randomized, double blind, and placebo controlled, and has been completed.
Yes. NDec-decithabine-tetrahydrouridine is also known as NDec, or oral decithabine-tetrahydrouridine. These names refer to the same investigational oral small molecule developed by Novo Nordisk for sickle cell disease.
The Phase 2 trial NCT05405114 enrolled adults 18 years of age and older of any sex with sickle cell disease. It did not include healthy volunteers. The study was conducted across the United States, Canada, France, Greece, India, Italy, Jordan, Lebanon, Oman, South Africa, Spain, Switzerland, Turkey, and the United Kingdom.