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Pregabaline
Pregabaline is a Small molecule drug developed by Rambam Health Care Campus. It is currently in Phase 2 development.
Pregabalin is a small molecule that modulates voltage-gated calcium channels, classified as a MODULATOR. It is used to treat conditions such as epilepsy, neuropathic pain, and generalized anxiety disorder, among others.
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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).
| 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 | Pregabaline |
|---|---|
| Sponsor | Rambam Health Care Campus |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Population Pharmacokinetics of Antiepileptic in Pediatrics
- Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia (NA)
- Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia (NA)
- Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing (PHASE4)
- Multimodal Versus Opioid aNalgesia in carDiAc Surgery (PHASE4)
- Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery (PHASE3)
- Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia (PHASE1, PHASE2)
- 'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug (NA)
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:
- Pregabaline CI brief — competitive landscape report
- Pregabaline updates RSS · CI watch RSS
- Rambam Health Care Campus portfolio CI
Frequently asked questions about Pregabaline
What is Pregabaline?
Who makes Pregabaline?
What development phase is Pregabaline in?
Related
- Manufacturer: Rambam Health Care Campus — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing