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Pregabalin 100mg
Pregabalin 100mg is a Small molecule drug developed by Hospital for Special Surgery, New York. It is currently in Phase 1 development. Also known as: Lyrica, PGB.
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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).
| 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 name | Pregabalin 100mg |
|---|---|
| Also known as | Lyrica, PGB |
| Sponsor | Hospital for Special Surgery, New York |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal (PHASE2)
- Evaluating the Effectiveness of Bilateral ESPB in Addition to Standard Analgesia at Reducing Opioid Consumption (NA)
- The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair (PHASE4)
- Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia (NA)
- Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair (PHASE4)
- A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery (PHASE4)
- Multimodal Versus Opioid aNalgesia in carDiAc Surgery (PHASE4)
- Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC (PHASE4)
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:
- Pregabalin 100mg CI brief — competitive landscape report
- Pregabalin 100mg updates RSS · CI watch RSS
- Hospital for Special Surgery, New York portfolio CI
Frequently asked questions about Pregabalin 100mg
What is Pregabalin 100mg?
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Related
- Manufacturer: Hospital for Special Surgery, New York — full pipeline
- Also known as: Lyrica, PGB
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing