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Perioperative Pregabalin
Perioperative Pregabalin is a Gabapentinoid; anticonvulsant; anxiolytic analgesic Small molecule drug developed by McMaster University. It is currently in Phase 3 development for Perioperative anxiety and pain reduction, Postoperative pain management. Also known as: Lyrica.
Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters and thereby decreasing neuropathic pain and anxiety.
Pregabalin is a small molecule that modulates voltage-gated calcium channels, classified as a MODULATOR. It has been studied in various clinical trials for conditions such as knee osteoarthritis, pain, postoperative pain, coronary artery disease, and coronary stenosis, often as part of multimodal analgesia.
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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 | Perioperative Pregabalin |
|---|---|
| Also known as | Lyrica |
| Sponsor | McMaster University |
| Drug class | Gabapentinoid; anticonvulsant; anxiolytic analgesic |
| Target | Alpha-2-delta-1 subunit of voltage-gated calcium channels |
| Modality | Small molecule |
| Therapeutic area | Pain Management; Perioperative Medicine |
| Phase | Phase 3 |
Mechanism of action
Pregabalin is a gabapentinoid that modulates calcium influx at nerve terminals by binding to the alpha-2-delta-1 subunit of presynaptic voltage-gated calcium channels. This reduces the release of glutamate, noradrenaline, and substance P, leading to analgesic and anxiolytic effects. In the perioperative setting, it is used to reduce postoperative pain, anxiety, and opioid consumption.
Approved indications
- Perioperative anxiety and pain reduction
- Postoperative pain management
Common side effects
- Dizziness
- Somnolence
- Headache
- Dry mouth
- Blurred vision
Key clinical trials
- Perioperative Pregabalin in Ureteroscopy (PHASE2, PHASE3)
- Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt) (PHASE2)
- The Efficacy of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery. (NA)
- Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair (PHASE4)
- Improving Perioperative Sleep Disorders (PHASE1)
- Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty (NA)
- Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery (PHASE4)
- Effect of Perioperative Oral Pregabalin in Total Knee Replacement (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:
- Perioperative Pregabalin CI brief — competitive landscape report
- Perioperative Pregabalin updates RSS · CI watch RSS
- McMaster University portfolio CI
Frequently asked questions about Perioperative Pregabalin
What is Perioperative Pregabalin?
How does Perioperative Pregabalin work?
What is Perioperative Pregabalin used for?
Who makes Perioperative Pregabalin?
Is Perioperative Pregabalin also known as anything else?
What drug class is Perioperative Pregabalin in?
What development phase is Perioperative Pregabalin in?
What are the side effects of Perioperative Pregabalin?
What does Perioperative Pregabalin target?
Related
- Drug class: All Gabapentinoid; anticonvulsant; anxiolytic analgesic drugs
- Target: All drugs targeting Alpha-2-delta-1 subunit of voltage-gated calcium channels
- Manufacturer: McMaster University — full pipeline
- Therapeutic area: All drugs in Pain Management; Perioperative Medicine
- Indication: Drugs for Perioperative anxiety and pain reduction
- Indication: Drugs for Postoperative pain management
- Also known as: Lyrica
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing