Last reviewed · How we verify

Collagen-PVP

Coordinación de Investigación en Salud, Mexico · Phase 3 active Small molecule Under review

Collagen-PVP is a Biomaterial/Wound healing agent Small molecule drug developed by Coordinación de Investigación en Salud, Mexico. It is currently in Phase 3 development for Wound healing and tissue regeneration. Also known as: Fibroquel.

Collagen-PVP is a composite biomaterial that combines collagen with polyvinylpyrrolidone to provide structural support and promote tissue regeneration and wound healing.

Collagen-PVP is a solution used in clinical trials for various conditions, including diabetes complications, perineal tear, and COVID-19, as well as a treatment for stenosing tenosynovitis in older adults with type 2 diabetes. It is an enzyme modality that targets a specific protease, likely related to its action on gliadin, based on its synonyms listed in ChEMBL.

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 nameCollagen-PVP
Also known asFibroquel
SponsorCoordinación de Investigación en Salud, Mexico
Drug classBiomaterial/Wound healing agent
ModalitySmall molecule
Therapeutic areaWound Care/Tissue Regeneration
PhasePhase 3

Mechanism of action

The collagen component serves as a natural extracellular matrix scaffold that facilitates cell adhesion and tissue formation, while the PVP (polyvinylpyrrolidone) acts as a biocompatible polymer that enhances the material's physical properties, stability, and bioavailability. This combination is designed to support hemostasis, wound closure, and tissue repair through both structural and biological mechanisms.

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 Collagen-PVP

What is Collagen-PVP?

Collagen-PVP is a Biomaterial/Wound healing agent drug developed by Coordinación de Investigación en Salud, Mexico, indicated for Wound healing and tissue regeneration.

How does Collagen-PVP work?

Collagen-PVP is a composite biomaterial that combines collagen with polyvinylpyrrolidone to provide structural support and promote tissue regeneration and wound healing.

What is Collagen-PVP used for?

Collagen-PVP is indicated for Wound healing and tissue regeneration.

Who makes Collagen-PVP?

Collagen-PVP is developed by Coordinación de Investigación en Salud, Mexico (see full Coordinación de Investigación en Salud, Mexico pipeline at /company/coordinaci-n-de-investigaci-n-en-salud-mexico).

Is Collagen-PVP also known as anything else?

Collagen-PVP is also known as Fibroquel.

What drug class is Collagen-PVP in?

Collagen-PVP belongs to the Biomaterial/Wound healing agent class. See all Biomaterial/Wound healing agent drugs at /class/biomaterial-wound-healing-agent.

What development phase is Collagen-PVP in?

Collagen-PVP is in Phase 3.

Related

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