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Vertebral bone marrow clot

Istituto Ortopedico Rizzoli · Phase 1 active Biologic ✓ Verified May 2026

Vertebral bone marrow clot is a Biologic drug developed by Istituto Ortopedico Rizzoli. It is currently in Phase 1 development.

Researchers have studied the use of vertebral bone marrow clot as a scaffold for posterior lumbar fusion in patients with degenerative spine diseases, with one completed clinical trial (NCT05936047) evaluating its efficacy. The vertebral bone marrow clot is a protein-based scaffold, specifically containing bone morphogenetic protein 2 (BMP-2), which plays a role in bone formation.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameVertebral bone marrow clot
SponsorIstituto Ortopedico Rizzoli
ModalityBiologic
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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Frequently asked questions about Vertebral bone marrow clot

What is Vertebral bone marrow clot?

Vertebral bone marrow clot is a Biologic drug developed by Istituto Ortopedico Rizzoli.

Who makes Vertebral bone marrow clot?

Vertebral bone marrow clot is developed by Istituto Ortopedico Rizzoli (see full Istituto Ortopedico Rizzoli pipeline at /company/istituto-ortopedico-rizzoli).

What development phase is Vertebral bone marrow clot in?

Vertebral bone marrow clot is in Phase 1.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing