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Helioblock SX

Loreal USA · Phase 3 active Small molecule Under review

Helioblock SX is a Small molecule drug developed by Loreal USA. It is currently in Phase 3 development for UV protection and photoprotection.

Helioblock SX is a topical sunscreen agent that provides broad-spectrum UV protection by absorbing and reflecting ultraviolet radiation.

Helioblock SX is a small molecule intervention used in clinical trials to study its effects on dry skin and sunburn. It was tested in a completed study (NCT00368563) to determine its ability to moisturize skin.

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 nameHelioblock SX
SponsorLoreal USA
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 3

Mechanism of action

The product is designed to protect skin from harmful UV exposure, likely combining multiple UV filters to achieve broad-spectrum protection (UVA and UVB). As a cosmetic/dermatological product from L'Oréal, it functions as a photoprotective barrier rather than a systemically-acting pharmaceutical agent.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Helioblock SX

What is Helioblock SX?

Helioblock SX is a Small molecule drug developed by Loreal USA, indicated for UV protection and photoprotection.

How does Helioblock SX work?

Helioblock SX is a topical sunscreen agent that provides broad-spectrum UV protection by absorbing and reflecting ultraviolet radiation.

What is Helioblock SX used for?

Helioblock SX is indicated for UV protection and photoprotection.

Who makes Helioblock SX?

Helioblock SX is developed by Loreal USA (see full Loreal USA pipeline at /company/loreal-usa).

What development phase is Helioblock SX in?

Helioblock SX is in Phase 3.

Related

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