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Intrathecal Baclofen Pump
Intrathecal Baclofen Pump is a GABA receptor agonist Small molecule drug developed by Amsterdam UMC, location VUmc. It is currently in Phase 2 development for Spasticity. Also known as: intrathecal baclofen treatment.
GABA_B receptor agonist
GABA_B receptor agonist Used for Spasticity.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Intrathecal Baclofen Pump |
|---|---|
| Also known as | intrathecal baclofen treatment |
| Sponsor | Amsterdam UMC, location VUmc |
| Drug class | GABA receptor agonist |
| Target | GABA_B receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
Baclofen acts as an agonist at the GABA_B receptor, which is involved in the regulation of muscle tone and spasticity.
Approved indications
- Spasticity
Common side effects
- Drowsiness
- Nausea
- Dizziness
Key clinical trials
- Predictive Factors for Succes of ITB in CP
- "Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function" (NA)
- Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) (NA)
- Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump (PHASE3)
- Long-term Surveillance of the MedStream Programmable Infusion System
- SISTERS: Spasticity In Stroke Study - Randomized Study (PHASE4)
- Continuous Intrathecal Baclofen Infusion for Chronic Spasticity (PHASE3)
- Dutch National ITB Study in Children With Cerebral Palsy (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:
- Intrathecal Baclofen Pump CI brief — competitive landscape report
- Intrathecal Baclofen Pump updates RSS · CI watch RSS
- Amsterdam UMC, location VUmc portfolio CI
Frequently asked questions about Intrathecal Baclofen Pump
What is Intrathecal Baclofen Pump?
How does Intrathecal Baclofen Pump work?
What is Intrathecal Baclofen Pump used for?
Who makes Intrathecal Baclofen Pump?
Is Intrathecal Baclofen Pump also known as anything else?
What drug class is Intrathecal Baclofen Pump in?
What development phase is Intrathecal Baclofen Pump in?
What are the side effects of Intrathecal Baclofen Pump?
What does Intrathecal Baclofen Pump target?
Related
- Drug class: All GABA receptor agonist drugs
- Target: All drugs targeting GABA_B receptor
- Manufacturer: Amsterdam UMC, location VUmc — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Spasticity
- Also known as: intrathecal baclofen treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing