Last reviewed 2026-05-23 · How we verify

SOR007 Ointment 2.0%

DFB Soria, LLC · Phase 1 active Small molecule ✓ Verified May 2026

SOR007 Ointment 2.0% is a Small molecule drug developed by DFB Soria, LLC. It is currently in Phase 1 development.

SOR007 Ointment 2.0% is a topical treatment being studied for various conditions, including cutaneous metastasis, plaque psoriasis, actinic keratosis, and cervical intraepithelial neoplasia. The active ingredient in SOR007 Ointment 2.0% is paclitaxel, an uncoated nanoparticle formulation.

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	SOR007 Ointment 2.0%
Sponsor	DFB Soria, LLC
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of Topical SOR007 Ointment for Cutaneous Metastases (PHASE1, PHASE2)
Study of SOR007 Ointment for Actinic Keratosis (PHASE2)
Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test (PHASE1)
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN) (PHASE2)

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:

SOR007 Ointment 2.0% CI brief — competitive landscape report
SOR007 Ointment 2.0% updates RSS · CI watch RSS
DFB Soria, LLC portfolio CI

Frequently asked questions about SOR007 Ointment 2.0%

What is SOR007 Ointment 2.0%?

SOR007 Ointment 2.0% is a Small molecule drug developed by DFB Soria, LLC.

Who makes SOR007 Ointment 2.0%?

SOR007 Ointment 2.0% is developed by DFB Soria, LLC (see full DFB Soria, LLC pipeline at /company/dfb-soria-llc).

What development phase is SOR007 Ointment 2.0% in?

SOR007 Ointment 2.0% is in Phase 1.

Manufacturer: DFB Soria, LLC — full pipeline

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