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DLX105 Hydrogel

Delenex Therapeutics AG · Phase 2 active Small molecule Under review

DLX105 Hydrogel is a Local anesthetic Small molecule drug developed by Delenex Therapeutics AG. It is currently in Phase 2 development for Postoperative pain management.

DLX105 Hydrogel is a hydrogel formulation of a local anesthetic.

DLX105 Hydrogel is a small molecule intervention being studied for the treatment of Psoriasis Vulgaris in a Phase II clinical trial. It is a topical hydrogel formulation, likely containing hypochlorous acid, which is being compared to a placebo in a double-blind, randomized study.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameDLX105 Hydrogel
SponsorDelenex Therapeutics AG
Drug classLocal anesthetic
TargetSodium channels
ModalitySmall molecule
Therapeutic areaPain management
PhasePhase 2

Mechanism of action

DLX105 Hydrogel works by releasing a local anesthetic to provide pain relief. The exact mechanism of action is not well understood, but it is thought to involve the inhibition of sodium channels in nerve cells, preventing the transmission of pain signals.

Approved indications

Common side effects

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 DLX105 Hydrogel

What is DLX105 Hydrogel?

DLX105 Hydrogel is a Local anesthetic drug developed by Delenex Therapeutics AG, indicated for Postoperative pain management.

How does DLX105 Hydrogel work?

DLX105 Hydrogel is a hydrogel formulation of a local anesthetic.

What is DLX105 Hydrogel used for?

DLX105 Hydrogel is indicated for Postoperative pain management.

Who makes DLX105 Hydrogel?

DLX105 Hydrogel is developed by Delenex Therapeutics AG (see full Delenex Therapeutics AG pipeline at /company/delenex-therapeutics-ag).

What drug class is DLX105 Hydrogel in?

DLX105 Hydrogel belongs to the Local anesthetic class. See all Local anesthetic drugs at /class/local-anesthetic.

What development phase is DLX105 Hydrogel in?

DLX105 Hydrogel is in Phase 2.

What are the side effects of DLX105 Hydrogel?

Common side effects of DLX105 Hydrogel include Numbness, Tingling.

What does DLX105 Hydrogel target?

DLX105 Hydrogel targets Sodium channels and is a Local anesthetic.

Related

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