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Rexlemestrocel-L + HA Mixture
Rexlemestrocel-L + HA Mixture is a Allogeneic mesenchymal stem cell therapy Small molecule drug developed by Mesoblast, Ltd.. It is currently in Phase 3 development for Knee osteoarthritis, Tendon and ligament injuries.
Rexlemestrocel-L is an allogeneic mesenchymal stem cell therapy combined with hyaluronic acid that promotes tissue repair and reduces inflammation through paracrine signaling and immunomodulation.
Rexlemestrocel-L + HA mixture is being studied for its efficacy and safety in treating moderate to severe chronic low back pain associated with degenerative disc disease. This mixture is being compared to Rexlemestrocel-L alone and saline in a randomized, double-blind, controlled study.
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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 | Rexlemestrocel-L + HA Mixture |
|---|---|
| Sponsor | Mesoblast, Ltd. |
| Drug class | Allogeneic mesenchymal stem cell therapy |
| Modality | Small molecule |
| Therapeutic area | Regenerative Medicine / Orthopedics |
| Phase | Phase 3 |
Mechanism of action
Rexlemestrocel-L consists of bone marrow-derived mesenchymal stem cells that secrete anti-inflammatory cytokines and growth factors while the hyaluronic acid component provides a scaffold for cell delivery and tissue integration. The combination works to modulate the immune response, reduce fibrosis, and promote regeneration of damaged tissue through multiple paracrine mechanisms rather than direct cell differentiation.
Approved indications
- Knee osteoarthritis
- Tendon and ligament injuries
Common side effects
- Injection site pain or swelling
- Transient joint effusion
- Infection at injection site
Key clinical trials
- Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain (PHASE3)
- Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain (PHASE3)
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:
- Rexlemestrocel-L + HA Mixture CI brief — competitive landscape report
- Rexlemestrocel-L + HA Mixture updates RSS · CI watch RSS
- Mesoblast, Ltd. portfolio CI
Frequently asked questions about Rexlemestrocel-L + HA Mixture
What is Rexlemestrocel-L + HA Mixture?
How does Rexlemestrocel-L + HA Mixture work?
What is Rexlemestrocel-L + HA Mixture used for?
Who makes Rexlemestrocel-L + HA Mixture?
What drug class is Rexlemestrocel-L + HA Mixture in?
What development phase is Rexlemestrocel-L + HA Mixture in?
What are the side effects of Rexlemestrocel-L + HA Mixture?
Related
- Drug class: All Allogeneic mesenchymal stem cell therapy drugs
- Manufacturer: Mesoblast, Ltd. — full pipeline
- Therapeutic area: All drugs in Regenerative Medicine / Orthopedics
- Indication: Drugs for Knee osteoarthritis
- Indication: Drugs for Tendon and ligament injuries
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing