Last reviewed 2026-06-01 · How we verify

Local Anesthetic Solution and Dexmedetomedine

Sameh Fathy · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 0/100

Local Anesthetic Solution and Dexmedetomedine is a Small molecule drug developed by Sameh Fathy. It is currently in Phase 1 development. Also known as: Marcaine and Precedex.

Dexmedetomidine is used in combination with subtenon's block for pediatric strabismus surgery to reduce emergence agitation. Local anesthetic solution is used in laryngeal mask airway and subtenon's block procedures, including in pediatric strabismus surgery with sevoflurane anesthesia.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Local Anesthetic Solution and Dexmedetomedine
Also known as	Marcaine and Precedex
Sponsor	Sameh Fathy
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery (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:

Local Anesthetic Solution and Dexmedetomedine CI brief — competitive landscape report
Local Anesthetic Solution and Dexmedetomedine updates RSS · CI watch RSS
Sameh Fathy portfolio CI

Frequently asked questions about Local Anesthetic Solution and Dexmedetomedine

What is Local Anesthetic Solution and Dexmedetomedine?

Local Anesthetic Solution and Dexmedetomedine is a Small molecule drug developed by Sameh Fathy.

Who makes Local Anesthetic Solution and Dexmedetomedine?

Local Anesthetic Solution and Dexmedetomedine is developed by Sameh Fathy (see full Sameh Fathy pipeline at /company/sameh-fathy).

Is Local Anesthetic Solution and Dexmedetomedine also known as anything else?

Local Anesthetic Solution and Dexmedetomedine is also known as Marcaine and Precedex.

What development phase is Local Anesthetic Solution and Dexmedetomedine in?

Local Anesthetic Solution and Dexmedetomedine is in Phase 1.

Manufacturer: Sameh Fathy — full pipeline
Also known as: Marcaine and Precedex

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing