EMLA Topical Product

American University of Beirut Medical Center · Phase 3 active Small molecule

EMLA Topical Product is a Topical local anesthetic Small molecule drug developed by American University of Beirut Medical Center. It is currently in Phase 3 development for Topical anesthesia for minor surgical procedures and skin procedures, Pain relief for dermatological treatments. Also known as: Eutectic Mixture of Local Anesthetics.

EMLA is a topical anesthetic cream containing lidocaine and prilocaine that blocks sodium channels in nerve fibers to produce local anesthesia and analgesia.

EMLA is a topical anesthetic cream containing lidocaine and prilocaine that blocks sodium channels in nerve fibers to produce local anesthesia and analgesia. Used for Topical anesthesia for minor surgical procedures and skin procedures, Pain relief for dermatological treatments.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• 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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	EMLA Topical Product
Also known as	Eutectic Mixture of Local Anesthetics
Sponsor	American University of Beirut Medical Center
Drug class	Topical local anesthetic
Target	Voltage-gated sodium channels
Modality	Small molecule
Therapeutic area	Dermatology / Pain Management
Phase	Phase 3

Mechanism of action

EMLA (Eutectic Mixture of Local Anesthetics) works by penetrating the skin and numbing nerve endings through inhibition of sodium influx in nerve cell membranes. The eutectic formulation allows both lidocaine and prilocaine to exist as an oil-in-water emulsion at room temperature, enhancing skin penetration. This produces reversible local anesthesia suitable for minor surgical procedures and painful dermatological treatments.

Approved indications

• Topical anesthesia for minor surgical procedures and skin procedures
• Pain relief for dermatological treatments

Common side effects

• Skin blanching or erythema
• Temporary skin irritation
• Allergic contact dermatitis

Key clinical trials

• EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers (PHASE2)
• Comparative Study of Two Topical Anesthetics Prior to Fractional Nonablative Laser Treatment of the Face (PHASE2, PHASE3)
• Emla-Cream as Pain Relief During Pneumococcal Vaccination (NA)
• Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion (NA)
• Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting (PHASE1, PHASE2)
• The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children (NA)
• Local Anesthesia Before Bulkamid Injection (NA)
• Ice Versus EMLA for Pain in Laser Hair Removal (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:

• EMLA Topical Product CI brief — competitive landscape report
• EMLA Topical Product updates RSS · CI watch RSS
• American University of Beirut Medical Center portfolio CI

Frequently asked questions about EMLA Topical Product

What is EMLA Topical Product?

EMLA Topical Product is a Topical local anesthetic drug developed by American University of Beirut Medical Center, indicated for Topical anesthesia for minor surgical procedures and skin procedures, Pain relief for dermatological treatments.

How does EMLA Topical Product work?

EMLA is a topical anesthetic cream containing lidocaine and prilocaine that blocks sodium channels in nerve fibers to produce local anesthesia and analgesia.

What is EMLA Topical Product used for?

EMLA Topical Product is indicated for Topical anesthesia for minor surgical procedures and skin procedures, Pain relief for dermatological treatments.

Who makes EMLA Topical Product?

EMLA Topical Product is developed by American University of Beirut Medical Center (see full American University of Beirut Medical Center pipeline at /company/american-university-of-beirut-medical-center).

Is EMLA Topical Product also known as anything else?

EMLA Topical Product is also known as Eutectic Mixture of Local Anesthetics.

What drug class is EMLA Topical Product in?

EMLA Topical Product belongs to the Topical local anesthetic class. See all Topical local anesthetic drugs at /class/topical-local-anesthetic.

What development phase is EMLA Topical Product in?

EMLA Topical Product is in Phase 3.

What are the side effects of EMLA Topical Product?

Common side effects of EMLA Topical Product include Skin blanching or erythema, Temporary skin irritation, Allergic contact dermatitis.

What does EMLA Topical Product target?

EMLA Topical Product targets Voltage-gated sodium channels and is a Topical local anesthetic.

Related

• Drug class: All Topical local anesthetic drugs
• Target: All drugs targeting Voltage-gated sodium channels
• Manufacturer: American University of Beirut Medical Center — full pipeline
• Therapeutic area: All drugs in Dermatology / Pain Management
• Indication: Drugs for Topical anesthesia for minor surgical procedures and skin procedures
• Indication: Drugs for Pain relief for dermatological treatments
• Also known as: Eutectic Mixture of Local Anesthetics