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nonmyeloablative stem cell transplant

Beth Israel Deaconess Medical Center · Phase 1 active Small molecule ✓ Verified May 2026

nonmyeloablative stem cell transplant is a Small molecule drug developed by Beth Israel Deaconess Medical Center. It is currently in Phase 1 development.

Nonmyeloablative stem cell transplant is a treatment approach used for various hematological conditions, including leukemia, lymphoma, and myelodysplastic syndromes, as indicated by ClinicalTrials.gov. This treatment involves the use of immunosuppressive agents such as cyclosporine and mycophenolate mofetil, and may also include the use of pentostatin, as seen in clinical trials.

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 namenonmyeloablative stem cell transplant
SponsorBeth Israel Deaconess Medical Center
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about nonmyeloablative stem cell transplant

What is nonmyeloablative stem cell transplant?

nonmyeloablative stem cell transplant is a Small molecule drug developed by Beth Israel Deaconess Medical Center.

Who makes nonmyeloablative stem cell transplant?

nonmyeloablative stem cell transplant is developed by Beth Israel Deaconess Medical Center (see full Beth Israel Deaconess Medical Center pipeline at /company/beth-israel-deaconess-medical-center).

What development phase is nonmyeloablative stem cell transplant in?

nonmyeloablative stem cell transplant is in Phase 1.

Related

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