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Xenograft
Xenograft is a Biologic drug developed by National University of Malaysia. It is currently in Phase 3 development. Also known as: bovine derived xenograft.
Xenograft is a type of tissue or organ transplant from one species to another, used in medical treatments such as dental extraction, wound healing, and dental diseases. In clinical trials, Xenograft products like Vallos, Vallomix, and Vallos-F are being studied for their effectiveness in treating conditions such as peri-implantitis and crestal bone loss.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Xenograft |
|---|---|
| Also known as | bovine derived xenograft |
| Sponsor | National University of Malaysia |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD (PHASE1, PHASE2)
- Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel (PHASE2)
- The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation (NA)
- Elamrousy Novel Approach of Socket Shield Technique (NA)
- Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer (NA)
- L-PRF Versus Sticky Bone Grafting of the Jumping Gap in AI-assisted Computer-Guided Socket Shield Immediate Implantation (NA)
- Biologicals in Management of Intra-Bony Defects (NA)
- Autogenous Periosteal Pedicle Graft Versus Pericardium Membrane in Management of Periodontal Intrabony Defects in Stage III Periodontitis (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xenograft CI brief — competitive landscape report
- Xenograft updates RSS · CI watch RSS
- National University of Malaysia portfolio CI
Frequently asked questions about Xenograft
What is Xenograft?
Who makes Xenograft?
Is Xenograft also known as anything else?
What development phase is Xenograft in?
Related
- Manufacturer: National University of Malaysia — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: bovine derived xenograft
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing