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Prochymal®
Prochymal® is a Stem cell therapy Biologic drug developed by Mesoblast, Inc.. It is currently in Phase 3 development for Graft-versus-host disease. Also known as: Mesenchymal Stem Cells, Remestemcel-L, ex vivo cultured adult human mesenchymal stem cells, Prochymal.
Prochymal is a mesenchymal stem cell therapy that aims to modulate the immune system and promote tissue repair.
Prochymal is a mesenchymal stem cell therapy that aims to modulate the immune system and promote tissue repair. Used for Graft-versus-host disease.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Prochymal® |
|---|---|
| Also known as | Mesenchymal Stem Cells, Remestemcel-L, ex vivo cultured adult human mesenchymal stem cells, Prochymal, Ex-vivo Cultured Adult Human Mesenchymal Stem Cells |
| Sponsor | Mesoblast, Inc. |
| Drug class | Stem cell therapy |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
It is believed to exert its effects through the release of anti-inflammatory cytokines and growth factors, which help to reduce inflammation and promote healing in damaged tissues.
Approved indications
- Graft-versus-host disease
Common side effects
- Infusion-related reactions
Key clinical trials
- Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease (PHASE3)
- Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI) (PHASE2)
- Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease (PHASE3)
- Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease (PHASE3)
- PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) (PHASE2)
- Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
- Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD) (PHASE3)
- Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD) (PHASE2)
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:
- Prochymal® CI brief — competitive landscape report
- Prochymal® updates RSS · CI watch RSS
- Mesoblast, Inc. portfolio CI
Frequently asked questions about Prochymal®
What is Prochymal®?
How does Prochymal® work?
What is Prochymal® used for?
Who makes Prochymal®?
Is Prochymal® also known as anything else?
What drug class is Prochymal® in?
What development phase is Prochymal® in?
What are the side effects of Prochymal®?
Related
- Drug class: All Stem cell therapy drugs
- Manufacturer: Mesoblast, Inc. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Graft-versus-host disease
- Also known as: Mesenchymal Stem Cells, Remestemcel-L, ex vivo cultured adult human mesenchymal stem cells, Prochymal, Ex-vivo Cultured Adult Human Mesenchymal Stem Cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing