Drugs / NVD003
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05693558 | Nov 2022 → Jan 2025 | congenital pseudoarthrosis of the tibia | Novadip Biosciences | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07112443 | Sep 2025 → Oct 2026 expected | congenital pseudoarthrosis of the tibia | Novadip Biosciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-06-30 | Novadip Biosciences | Results Novadip and Cliniques universitaires Saint-Luc report positive results for compassionate use of NVD003 on four pediatric patients novadip.com ↗
Subsequent four to seven years of clinical follow-ups showed that each of the four patients had successful outcomes, achieving bone repair with no subsequent refracture. |
| 2025-06-23 | Novadip Biosciences | Regulatory Novadip receives RMAT designation for NVD003, its regenerative treatment for congenital pseudarthosis of the tibia novadip.com ↗
This designation can only be granted within the context of an IND, which Novadip received in 2021. |
| 2025-04-29 | Novadip Biosciences | Results Novadip releases five-year follow-up results for NVD003, regenerative treatment for severe bone non-union of lower limb novadip.com ↗
The five-year safety and efficacy data demonstrates that NVD003 readily osteointegrates, and is not subject to resorption, thus promoting durable bone union, even under the challenging conditions of compromised bone healing. |
| 2025-01-31 | Novadip Biosciences | Results Novadip reports 12-month results from phase 1b/2a trial of NVD003 to treat rare pediatric disease Congenital Pseudarthrosis of the Tibia novadip.com ↗
Combining the 12-month results from this trial together with those from four other children previously treated with NVD003 in two compassionate use programs in Belgium, 88% of patients, most of whom had prior failed surgeries, achieved healing of their fractures with NVD003. |
| 2022-12-08 | Novadip Biosciences | Results Novadip Biosciences SA Announces Positive Results from Phase 1/2 Clinical Trial in Patients with Severe Bone Non-Union of the Lower Limb Following Trauma novadip.com ↗
Rapid bone formation was confirmed at three months post-implantation in all patients |
| 2021-03-04 | Novadip Biosciences | Regulatory IND approval from the FDA for regenerative bone product NVD-003 novadip.com ↗
Novadip Biosciences (“Novadip”), a clinical stage company developing treatments to regenerate impaired tissues in patients with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for its autologous cell therapy product NVD 003 for the treatment of Congenital Pseudarthrosis of the Tibia (“CPT”). |
| 2020-12-23 | Novadip Biosciences | Regulatory 23 décembre 2020 – Visite de Willy Borsus, Ministre de l’Economie, du Commerce extérieur, de la Recherche et de l’Innovation novadip.com ↗
Novadip Biosciences (“Novadip”), a clinical stage company developing treatments to regenerate impaired tissues in patients with significant unmet medical needs, today announces that the U.S. Food and Drug Administration (FDA) has granted Rare Paediatric Disease designation and Orphan Drug designation for NVD 003, a cell therapy for the treatment of Congenital Pseudarthrosis of the Tibia (“CPT”), a rare but serious and debilitating condition, that primarily affects children with devastating consequences. |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NVD003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07112443 ↗ |
| Modality | Cell therapy | “derived from autologous adipose stem cells” NCT07112443 ↗ |