Last reviewed · How we verify

NPC-12Y gel

Nobelpharma · Phase 3 active Small molecule

NPC-12Y gel is a Small molecule drug developed by Nobelpharma. It is currently in Phase 3 development for Wound healing and tissue regeneration (specific indication under investigation in Phase 3).

NPC-12Y is a topical gel formulation designed to promote wound healing and tissue regeneration through growth factor delivery.

NPC-12Y is a topical gel formulation designed to promote wound healing and tissue regeneration through growth factor delivery. Used for Wound healing and tissue regeneration (specific indication under investigation in Phase 3).

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 nameNPC-12Y gel
SponsorNobelpharma
ModalitySmall molecule
Therapeutic areaDermatology/Wound Care
PhasePhase 3

Mechanism of action

NPC-12Y gel is a regenerative medicine product that appears to work by delivering bioactive compounds to enhance wound healing processes. The exact molecular mechanism is proprietary to Nobelpharma, but topical gels in this class typically promote angiogenesis, collagen deposition, and epithelialization at the wound site.

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 NPC-12Y gel

What is NPC-12Y gel?

NPC-12Y gel is a Small molecule drug developed by Nobelpharma, indicated for Wound healing and tissue regeneration (specific indication under investigation in Phase 3).

How does NPC-12Y gel work?

NPC-12Y is a topical gel formulation designed to promote wound healing and tissue regeneration through growth factor delivery.

What is NPC-12Y gel used for?

NPC-12Y gel is indicated for Wound healing and tissue regeneration (specific indication under investigation in Phase 3).

Who makes NPC-12Y gel?

NPC-12Y gel is developed by Nobelpharma (see full Nobelpharma pipeline at /company/nobelpharma).

What development phase is NPC-12Y gel in?

NPC-12Y gel is in Phase 3.

Related

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