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Solution for Injection in Sham Block
Solution for Injection in Sham Block is a Small molecule drug developed by Wake Forest University Health Sciences. It is currently in Phase 3 development for Treatment of various conditions in clinical trials. Also known as: Lidocaine.
This drug is a solution for injection in a sham block, which is used to treat various conditions.
A solution for injection in a sham block is Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution. This solution has been studied in clinical trials for various conditions, including analgesia, pain, and postoperative pain, often in combination with other interventions such as periarticular injection or continuous femoral nerve block.
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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 | Solution for Injection in Sham Block |
|---|---|
| Also known as | Lidocaine |
| Sponsor | Wake Forest University Health Sciences |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
The exact mechanism of this drug is unknown, but it is used as a control in clinical trials to compare the effects of the active treatment.
Approved indications
- Treatment of various conditions in clinical trials
Common side effects
Key clinical trials
- Postop Pain Management in Pituitary Tumour Patients (PHASE4)
- SII Levels Following PENG Block in Hip Arthroplasty (NA)
- PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty (PHASE4)
- Percutaneous Electrical Nerve Stimulation As Alternative To Nerve Blocks In Anesthesia, Pain Medicine And Rehabilitation Of Nonspecific Chronic Pain (PHASE4)
- NLR and PLR Levels Following PENG Block in Hip Arthroplasty (PHASE4)
- A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) (PHASE3)
- Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy (PHASE4)
- Hysteroscopy Anesthesia for Relief of 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:
- Solution for Injection in Sham Block CI brief — competitive landscape report
- Solution for Injection in Sham Block updates RSS · CI watch RSS
- Wake Forest University Health Sciences portfolio CI
Frequently asked questions about Solution for Injection in Sham Block
What is Solution for Injection in Sham Block?
How does Solution for Injection in Sham Block work?
What is Solution for Injection in Sham Block used for?
Who makes Solution for Injection in Sham Block?
Is Solution for Injection in Sham Block also known as anything else?
What development phase is Solution for Injection in Sham Block in?
Related
- Manufacturer: Wake Forest University Health Sciences — full pipeline
- Indication: Drugs for Treatment of various conditions in clinical trials
- Also known as: Lidocaine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing