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collagen (Gelfix / Biopad / Condress)

✓ Approved

Merck & Co. · therapeutic agent

What is collagen?

collagen is a therapeutic agent developed by Merck & Co.. It is approved for therapeutic indications via topical.

Drug Profile

Brand NamesGelfix, Biopad, Condress
CompanyMerck & Co.
RouteTopical
StatusApproved
Sources: ClinicalTrials.gov, Merck & Co.

Therapeutic Indications

collagen is developed for 4 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
General disorders and administration site conditionsImpaired healing✓ Approved
Skin and subcutaneous tissue disordersDiabetic foot✓ Approved
Skin and subcutaneous tissue disordersDecubitus ulcer✓ Approved
Vascular disordersPeripheral venous disease✓ Approved

Related Research Articles

PubMedCaspian journal of internal medicine2026-08-30

Collagen-based dressings for diabetic foot ulcers: A systematic review.

Rahimi Shakiba S, Hosseingholizade Mahsa M, Hashemi-Madani Nahid N, Emami Zahra Z et al.

To evaluate the efficacy and safety of collagen-based dressings in the management of diabetic foot ulcers (DFUs), compared to standard wound care (SWC), human amniotic membrane allografts (hAMA), and decellularized extracellular matrix (dECM) products. A systematic review of randomized controlled trials (RCTs) and cohort studies published between December 2013 and March 2025 was conducted using PubMed, Scopus, and Web of Science. Eligible studies assessed collagen-based dressings for DFUs, with primary outcomes including wound area reduction, closure rates, and healing time. Adverse events were considered secondary outcomes. Due to heterogeneity, findings were narratively synthesized by dressing type. Twenty-two studies (15 RCTs, 7 cohort studies) were included. Collagen-based dressings consistently outperformed SWC, achieving greater wound reduction (54.5--88.2%), higher closure rates (22.2--82.4%), and shorter healing times (21--83.5 days), with no serious treatment-related adverse events. Helicoll showed superior performance (wound reduction: 84--86.5%; closure: 50--71.4%). Comparisons with hAMA and dECM yielded mixed and heterogeneous results, without consistent evidence of superiority. RCTs favored hAMA over Apligraf, while some real-world studies reported the opposite. Findings on collagen/ORC/silver dressings versus dECM were also inconsistent. Collagen-based dressings are safe and effective for improving DFU healing when compared with standard wound care. However, current evidence is insufficient and heterogeneous to establish superiority over other advanced biologic therapies. Further head-to-head randomized trials are warranted.

PMID 42668683
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PubMedJournal of molecular histology2026-08-30

Early effects of X-ray irradiation on rat incisor periodontal ligament morphology and MMP-2 expression.

Fischborn Amanda Regina AR, Sartor Letícia L, Omar Nadia Fayez NF, Gomes Jose Rosa JR

Radiotherapy is an effective treatment for head and neck cancer; however, it also induces alterations in healthy oral tissues. Although late radiation-induced damage has been extensively investigated, the early progression of morphological and extracellular matrix changes in the periodontal ligament (PDL) remains poorly understood. This study investigated early radiation-induced changes in collagen organisation, the type I-to-type III collagen ratio, and matrix metalloproteinase-2 (MMP-2) expression in the lingual PDL of rat incisors. Adult Wistar rats were allocated to four irradiated groups (n = 5 per group) and exposed to a single 15 Gy X-ray dose directed to the head. Animals were euthanized at 4, 9, 14, or 25 days after irradiation. A non-irradiated control group was euthanized on day 4. Left hemimandibles were fixed, decalcified, embedded in paraffin, and sectioned. Histological analyses were performed using hematoxylin and eosin, Masson's trichrome, and Picrosirius Red staining under polarized light. MMP-2 expression was evaluated by immunohistochemistry and quantified by grayscale pixel intensity analysis. Irradiation induced progressive alterations in the lingual periodontal ligament. Fibroblast nuclei exhibited morphological features consistent with cellular injury beginning on day 4, with increasing changes at subsequent time points. These changes were accompanied by progressive disorganisation of collagen bundles, increased interfibrillar spaces, and loss of normal extracellular matrix architecture. Picrosirius Red analysis demonstrated a reduction in the type I-to-type III collagen ratio on days 4, 9, and 14 after irradiation, supporting the morphological changes observed with H.E and Masson's trichrome staining. MMP-2 expression increased significantly on day 4, reached its highest level on day 9, and then progressively decreased on days 14 and 25. A single dose of X-ray irradiation induces early morphological and extracellular matrix alterations in the rat incisor periodontal ligament. The temporal association between increased MMP-2 expression, collagen fibre disorganisation, and a decreased type I-to-type III collagen ratio suggests that MMP-2 is associated with the early extracellular matrix remodelling observed on days 4 and 9 after irradiation. The subsequent decline in MMP-2 expression was accompanied by an apparent partial restoration of collagen fibre organisation on days 14 and 25.

PMID 42669096
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PubMedAdvances in radiation oncology2026-08-30

Systemic Copper Chelation Reduces Collagen Deposition and Preserves Secretory Function in Irradiated Mouse Salivary Glands.

Nam Kihoon K, Maslow Frank M FM, Santos Harim Tavares Dos HTD, Shanbhag Vinit C VC et al.

Radiation therapy (RT) for head and neck cancer commonly causes fibrosis of the salivary gland (SG) and loss of secretory function. We previously demonstrated that transdermal injection of the copper chelator tetrathiomolybdate into irradiated submandibular glands reduced the early deposition of fibrillar collagen and preserved their integrity and function. Although these studies identified copper metabolism as a novel therapeutic target to control RT-induced damage to the SG, local delivery of copper chelators in human SG presents clinical hurdles including specialized personnel and equipment needed for administration together with the discomfort felt by patients upon receiving this treatment. To overcome these issues, the current study investigated whether systemic administration of tetrathiomolybdate (TTM) via drinking water could similarly reduce collagen deposition and preserve secretory function. Mice received TTM in drinking water (0.1 mg/mL) beginning 7 days before and continuing through 7 days after a single 15-Gy dose of RT to the neck. Systemic TTM exposure and copper bioavailability were assessed by measuring molybdenum and copper levels and serum ceruloplasmin activity. RT-induced SG injury was evaluated by collagen deposition, histopathology, epithelial integrity, and stimulated saliva secretion. Systemically administered TTM reached the submandibular gland and reversibly reduced copper bioavailability, as demonstrated by increased molybdenum levels, reduced copper-to-molybdenum ratios, and suppression of serum ceruloplasmin activity. Moreover, TTM treatment attenuated RT-induced collagen deposition and epithelial damage and promoted recovery of ZO-1 expression. Finally, at 30 days after RT, stimulated saliva flow was significantly higher in TTM-treated irradiated mice than in irradiated mice receiving regular water. Systemic TTM administration reduces copper bioavailability, attenuates RT-induced collagen deposition and epithelial injury, and preserves SG secretory function. These findings support systemic copper chelation as a less invasive alternative to local TTM delivery for limiting RT-induced SG damage.

PMID 42668541
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PubMedAdvanced science (Weinheim, Baden-Wurttemberg, Germany)2026-08-30

Space Jam-Ming: Generating Interstitial Space Using Fragmented Granular GelMA to Investigate Novel Paradigms of Cancer Metastasis.

Vahala Danielle D, Lee Zhuang Min ZM, Amos Sebastian E SE, Son Dong Woo DW et al.

The tumor microenvironment undergoes extensive remodeling during cancer progression, resulting in increased collagen, altered tissue mechanics, and the formation of collagen tracks that permit migration. However, how the extracellular matrix (ECM) regulates cellular plasticity remains less known. Cellular plasticity is essential for successful metastasis, as cells undergo epithelial-to-mesenchymal transition and adherent-to-suspension transition (AST). Studies have begun to use 3D photo-crosslinkable hydrogels, but, unlike in vivo ECM, hydrogel stiffness is inextricably linked to porosity. In this study, we propose a fragmented gelatin methacryloyl (GelMA) scaffold that controls stiffness independently from porosity. When encapsulated as single cells, non-metastatic breast cancer cells do not exhibit growth restriction, whilst pre-engineered metastatic breast cancer cells show altered mechanosensitivity and enhanced migration (p < 0.05). We next study the role of AST in cellular migration and observe similar velocity to invasive metastatic cells. Interestingly, non-metastatic cells showed AST-dependent migration within interstitial spaces, which was enhanced in the stiff scaffold (p < 0.05). AST induction significantly increased Lamin A/C (associated with providing nuclear stability for circulating tumor cells) and reduced nuclear yes-associated protein (YAP) (necessary for cell detachment). Our data highlights the importance of incorporating micro-scale porosity and presents a promising platform for the study of cellular growth and migration.

PMID 42669624
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PubMedJournal of autoimmunity2026-08-30

Unveiling the role of abnormal copper metabolism in systemic lupus erythematosus.

Chen Zigu Z, Yan Shaowei S, Deng Chuiwen C, Wang Weichao W et al.

Metabolic dysregulation is increasingly implicated in systemic lupus erythematosus (SLE). Given the crucial role of copper (Cu) in immunity, its specific metabolic alterations in SLE remain poorly understood. By integrating cross-sectional exploratory research, transcriptomic analysis, and murine experiments, this study aims to investigate the phenotypic signatures of aberrant Cu metabolism in SLE, alongside its molecular mechanisms and therapeutic potential. In blood samples from patients and healthy controls, Cu concentrations and stable isotopic ratios (δ65Cu) were measured using inductively coupled plasma mass spectrometry (ICP-MS) and multi-collector ICP-MS, respectively. To explore the mechanisms, molecular alterations were assessed using publicly available blood transcriptomic datasets and Western blotting. The effects of Cu modulation on disease progression were further evaluated in lupus-prone MRL/lpr mice treated with the Cu chelator ammonium tetrathiomolybdate (TTM). Statistical analyses included between-group comparisons, analysis of covariance and multivariable logistic regression for confounder adjustment, association analyses, and gene set enrichment analyses. Autoimmune disease patients (n = 50), particularly SLE patients (n = 21), exhibited distinct Cu metabolic profiles compared to healthy controls (n = 34), with elevated plasma Cu concentration (mean 1.38 [95% CI 1.21-1.56] vs 1.20 [95% CI 1.13-1.28] μg/g; P = 0.058) but decreased δ65Cu in both plasma (mean -0.33‰ [95% CI -0.45‰--0.21‰] vs -0.05‰ [95% CI -0.13‰-0.03‰]; P < 0.0001) and blood cells (mean 0.23‰ [95% CI 0.09‰-0.38‰] vs 0.98‰ [95% CI 0.88‰-1.09‰]; P < 0.0001). Key Cu buffering (albumin, ceruloplasmin) and transport (STEAP4) proteins were dysregulated in SLE. Blood transcriptome analysis of SLE patients (n = 264) and healthy subjects (n = 83) from a public database revealed multiple dysregulated genes in Cu metabolism, which were associated with Cu uptake/efflux and pathways related to mitochondrial respiration and collagen cross-linking. In the MRL/lpr mice, limiting Cu bioavailability via TTM alleviated disease severity, reducing lymphadenopathy and kidney inflammation and fibrosis. We highlighted Cu metabolism abnormalities in SLE, proposing blood cell δ65Cu as a potential exploratory biomarker. Aberrant Cu metabolism may contribute to SLE pathology, potentially through mitochondrial and collagen-related pathways, and could be modulated by Cu chelation, suggesting a novel perspective for therapeutic intervention in SLE.

PMID 42669218
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PubMedInternational journal of pharmaceutics: X2026-08-30

Water-triggered in-situ gelling phospholipid oil enema for enhanced budesonide delivery and mucosal healing in ulcerative colitis.

Ouyang Ting T, Chen Yumo Y, Jia Yiying Y, Li Jiarui J et al.

Budesonide (BUD) enema therapy for ulcerative colitis (UC) is limited by poor solubility, inadequate bio-adhesion, and rapid clearance due to intestinal peristalsis. To address the limitations of conventional budesonide enemas, we designed a water-triggered in situ phase-transition phospholipid formulation (termed PG oil). This system comprises soybean phosphatidylcholine (PC-98), glyceryl dioleate (GDO), propylene glycol, and anhydrous ethanol, and achieves markedly enhanced BUD solubilization (35 mg/mL), in contrast to its negligible aqueous solubility (0.021 mg/mL). Upon contact with colonic fluid, PG oil rapidly underwent sol-gel transition, forming a bio-adhesive lamellar liquid crystalline gel that serves as both a physical mucosal barrier and a sustained-release drug depot. In a dextran sulfate sodium (DSS)-induced colitis mouse model, rectal administration of BUD-PG oil (0.3 mg/kg) significantly outperformed free BUD suspension, as evidenced by restored body weight, reduced disease activity index, normalized colon length, and decreased spleen index. Immunohistochemistry revealed marked suppression of pro-inflammatory cytokines (IL-6, TNF-α, IL-1β, MCP-1) in colonic tissue. Histological analysis demonstrated that BUD-PG promoted favorable mucosal repair characterized by reduced collagen deposition (Masson's trichrome: from 48.5% to 16.7%) while restoring gut barrier integrity through replenishment of goblet cells and upregulation of tight junction proteins (ZO-1, Occludin-1, Claudin-5, β-catenin). Collectively, this water-responsive in situ gelling phospholipid oil platform addresses critical limitations of conventional BUD enemas by combining sustained local drug delivery with physical mucosal protection, offering a promising therapeutic strategy for comprehensive mucosal healing in UC.

PMID 42668512
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