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Gabapentinoids
Gabapentinoids is a Small molecule drug developed by Major Extremity Trauma Research Consortium. It is currently in Phase 3 development. Also known as: Pregablin/Lyrica (NDC 00071-1014-68; manufacturer: Pfizer; encapsulated in size, AA empty capsule shells, backfilled with Avicel by Fisher Clinical Services, (Bristol) LLC,; Lyrica, NDC 00071-1018-68; manufacturer: Pfizer; encapsulated, in size AA empty capsule shells, backfilled with Avicel by Fisher Clinical.
Gabapentinoids are a class of small molecule drugs that modulate voltage-gated calcium channels. They are used to treat conditions such as pain, including postherpetic neuralgia and postsurgical pain management, as well as herpes zoster.
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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 | Gabapentinoids |
|---|---|
| Also known as | Pregablin/Lyrica (NDC 00071-1014-68; manufacturer: Pfizer; encapsulated in size, AA empty capsule shells, backfilled with Avicel by Fisher Clinical Services, (Bristol) LLC,; Lyrica, NDC 00071-1018-68; manufacturer: Pfizer; encapsulated, in size AA empty capsule shells, backfilled with Avicel by Fisher Clinical, Services (Bristol) LLC) |
| Sponsor | Major Extremity Trauma Research Consortium |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster (NA)
- An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service (PHASE3)
- The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions
- A Prospective Cohort Study on the Effect of Spinal Spinal Cord Injury on Sexual Function in Male Patients
- Prevalence of Gabapentinoids and Opioids in Geriatric Falls Patients
- Deprescribing for Older Dialysis Patients
- Effect of Transcutaneous Electrical Nerve Stimulation on CIPN Symptoms (NA)
- Focal Microvibration and Chronic Lumbosacral Radicular Pain (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:
- Gabapentinoids CI brief — competitive landscape report
- Gabapentinoids updates RSS · CI watch RSS
- Major Extremity Trauma Research Consortium portfolio CI
Frequently asked questions about Gabapentinoids
What is Gabapentinoids?
Who makes Gabapentinoids?
Is Gabapentinoids also known as anything else?
What development phase is Gabapentinoids in?
Related
- Manufacturer: Major Extremity Trauma Research Consortium — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Pregablin/Lyrica (NDC 00071-1014-68; manufacturer: Pfizer; encapsulated in size, AA empty capsule shells, backfilled with Avicel by Fisher Clinical Services, (Bristol) LLC,; Lyrica, NDC 00071-1018-68; manufacturer: Pfizer; encapsulated, in size AA empty capsule shells, backfilled with Avicel by Fisher Clinical, Services (Bristol) LLC)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing