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PG

PG-201 (Layla / PG201)

✓ Approved

PMG Pharm · therapeutic agent

What is PG-201?

PG-201 is a therapeutic agent developed by PMG Pharm. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesLayla, PG201
CompanyPMG Pharm
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, PMG Pharm

Therapeutic Indications

PG-201 is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Musculoskeletal and connective tissue disordersOsteoarthritis✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritisPhase III

Related Research Articles

PubMedGeriatrics & gerontology international2026-10-15

B-Type Natriuretic Peptide Is Associated With Sarcopenia in Older Patients Without Symptomatic Heart Failure.

Toba Ayumi A, Ishikawa Joji J, Tamura Yoshiaki Y, Araki Atsushi A et al.

B-type natriuretic peptide (BNP) has been identified as a biomarker of sarcopenia in community-dwelling populations and in patients with heart failure. However, it remains unclear whether BNP is associated with sarcopenia in the pre-heart failure stage in older adults with cardiometabolic diseases. In this cross-sectional study, BNP was measured in 697 older outpatients with cardiometabolic disease and no history of heart failure or atrial fibrillation. Sarcopenia was assessed using the Asian Working Group for Sarcopenia criteria 2019. The participants were grouped according to whether their BNP level was < 35 pg/mL, 35 ≤ BNP < 100 pg/mL, or ≥ 100 pg/mL in accordance with the Japanese guideline on diagnosis and treatment of heart failure. The mean age was 78.8 ± 6.8 years. Sarcopenia was present in 38% of patients. Natural log-transformed BNP was significantly related to gait speed (B = -0.278, SE = 0.128, p = 0.031) and hand grip strength (B = -0.016, SE = 0.007, p = 0.013) even after adjusting for age, sex, body mass index, estimated glomerular filtration rate, regular alcohol intake, smoking status, diabetes mellitus, dyslipidemia, hypertension, stroke, and antihypertensive medication use. Multivariate logistic regression analysis revealed that those with BNP ≥ 100 pg/mL had an increased risk of sarcopenia (OR 2.33, 95% CI 1.18-4.60), low appendicular skeletal mass index (OR 2.47, 95% CI 1.19-5.15), and low handgrip strength (OR 2.44, 95% CI 1.27-4.68). Increased BNP (≥ 100 pg/mL) was associated with sarcopenia even in individuals with cardiometabolic disease and no history of atrial fibrillation or symptomatic heart failure.

PMID 42876020
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PubMedJournal of human nutrition and dietetics : the official journal of the British Dietetic Association2026-10-15

Nutritional Risk and Unmet Nutritional Need in Ambulatory Patients Undergoing Systemic Anti-Cancer Therapies.

McLuskie Amy A, Angel Karen K, Maddocks Matthew M, Finucane Anne A et al.

Malnutrition is highly prevalent among cancer patients receiving systemic anti-cancer therapy (SACT) and is associated with poor treatment tolerance, reduced quality of life, and increased mortality. Despite recommendations, nutritional screening in the outpatient setting is inconsistently implemented and the prognostic significance of nutritional risk identified using a validated screening tool is still unclear. This study aimed to determine the prevalence of nutritional risk among patients receiving SACT, whether their nutritional needs were being met with dietetic input, and to examine associations with clinical outcomes, including treatment toxicity, dose reduction, hospital admission, and overall survival. In this prospective observational study, adult outpatients receiving SACT were invited to complete the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF), a nutritional screening tool. Nutritional risk using PG-SGA SF scores was assessed in relation to treatment toxicity, dose reduction, and hospital admission using multivariable regression models and survival was evaluated using Cox proportional hazards models, both adjusted for age, sex, metastatic disease, and performance status. Of 169 participants, 24.9% were at nutritional risk, PG-SGA SF score 4-8, and 10.7% at high risk ≥ 9, yet only 5.3% were in receipt of dietetic care. Higher PG-SGA SF scores were independently associated with increased treatment toxicity (OR: 1.2, 95% CI: 1.1-1.3, p = 0.003) and SACT dose reductions (OR: 1.2, 95% CI: 1.0-1.3, p = 0.040). Nutritional risk was not significantly associated with 30-day hospital admissions but was independently associated with overall survival (HR: 1.1, 95% CI: 1.0-1.2, p = 0.004). Nutritional risk identified using the PG-SGA SF independently predicted treatment toxicity, dose reduction, and survival in those receiving SACT. Despite over one-third of those meeting the criteria for dietetic intervention, only 5.3% were receiving dietetic care, indicating a substantial gap between dietetic need and provision. These results support implementation of routine screening, referral pathways, and a dedicated dietetic service integrated into oncology outpatient services.

PMID 42876050
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PubMedPakistan journal of biological sciences : PJBS2026-10-15

Procalcitonin and Interleukin-18 in Umbilical Cord Blood as Early Diagnostic Biomarkers for Early-Onset Neonatal Sepsis: A Case-Control Study.

Gusmaiyanto Devi D, Efrida Efrida E, Hardisman Hardisman H, Mayetti Mayetti M

<b>Background and Objective:</b> Early-onset neonatal sepsis (EONS) is a major cause of neonatal morbidity and mortality globally, yet its early diagnosis remains challenging due to the limited availability of rapid, reliable biomarkers at the time of birth. This study aimed to analyze procalcitonin (PCT) and Interleukin-18 (IL-18) levels measured from umbilical cord blood as early diagnostic biomarkers for EONS. <b>Materials and Methods:</b> An observational case-control study was conducted on 66 neonates born with at least one EONS risk factor at four hospitals in Riau Province, Indonesia. Subjects were classified into an EONS group (n = 33) and a non-EONS group (n = 33). Umbilical cord blood PCT and IL-18 were measured using an enzyme-linked immunosorbent assay. Normality was assessed using the Shapiro-Wilk test. Between-group differences were analyzed using the Mann-Whitney U test (α = 0.05). <b>Results:</b> The PCT levels in umbilical cord blood were significantly higher in the EONS group compared to the non-EONS group [median 322.77 (range: 66.70-2599.57) pg/mL vs. 45.9 (4.90-321.97) pg/mL; p<0.001]. The IL-18 levels were similarly elevated [median 564.00 (216.40-1979.00) pg/mL vs. 107.60 (-19.60-773.38) pg/mL; p<0.001]. Maternal fever history was significantly more frequent in the EONS group (36.4% vs. 6.1%; p = 0.005), as was colored amniotic fluid (93.9% vs. 45.5%; p<0.001). <b>Conclusion:</b> Umbilical cord blood PCT and IL-18 levels are significantly elevated in neonates with EONS and may serve as early diagnostic biomarkers for EONS when measured at the time of birth. Their combined use may improve early risk stratification and clinical decision-making in at-risk neonates.

PMID 42876180
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PubMedFrontiers in oncology2026-10-15

Implementation and feasibility of DPYD-guided fluoropyrimidine use in a gastrointestinal oncology clinic at an academic medical center.

Norris Madeline L ML, Nguyen Khoa A KA, Cicali Emily J EJ, Marquez Moyeno Wandyeind W et al.

Genetic variation in DPYD can result in reduced fluoropyrimidine (FP) metabolism and increased risk of severe toxicity. This DPYD test implementation pilot aimed to establish a feasible workflow for DPYD ordering sample collection and FP dose modifications at the University of Florida Health Cancer Institute. Following education on the clinical utility of DPYD testing, a consensus was reached with the University of Florida Health gastrointestinal oncology clinic on an implementation workflow. Novel clinical decision support (CDS) tools were developed including pre- and post-test inline warnings in chemotherapy treatment plans, clickable dose modification buttons, and a pharmacist-facing alert upon medication verification. Primary outcomes were feasibility metrics including rates and timing of test ordering and sample collection, genotype turnaround time, and clinician response to CDS tools (e.g., FP dose modifications). DPYD was ordered for 201 patients between July 2024 and March 2026. Most (180/201) orders were placed prior to chemotherapy in FP-naïve individuals, and 85% (153/180) were also collected pretreatment. The average genotype turnaround time was 5.0 ± 2.7 days. Results were available prior to chemotherapy for 80.3% (114/142) of all patients who received a FP-containing regimen and for 93.2% (110/118) of those with DPYD ordered and collected pretreatment. Nine patients had a deleterious DPYD variant; all who newly initiated a FP-containing regimen received a 50% dose reduction. DPYD test implementation with customized CDS tools to support test ordering and FP prescribing in an academic oncology clinic is feasible, with the majority of results returning prior to chemotherapy. Integrating new and unique processes into already established workflows helps achieve timely test ordering and sample collection.

PMID 42876758
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PubMedThe Egyptian journal of immunology2026-10-15

Elevated serum soluble PD-L1 is associated with adverse outcomes after autologous stem cell transplantation in transplant-eligible multiple myeloma patients.

Naguib Mary G MG, Fathy Merna M, Mohamed Haydi S HS, Moussa M M MM et al.

Multiple myeloma (MM) is a plasma-cell malignancy in which immune-evasion mechanisms may contribute to disease progression. Soluble programmed death-ligand 1 (PD-L1) has been associated with adverse outcomes in MM, but its prognostic significance before and after autologous stem cell transplantation (ASCT) remains incompletely defined. To evaluate serum PD-L1 concentrations before and six months after ASCT and to assess their associations with clinical outcomes, including overall survival (OS), disease-free survival (DFS), relapse, and graft failure. This prospective observational study included 40 transplant-eligible patients with MM treated at the Ain Shams University Bone Marrow Center. Serum PD-L1 was measured by ELISA before ASCT and six months after transplantation. Clinical outcomes were assessed during follow-up through 180 days, and associations with survival and adverse outcomes were evaluated using correlation analysis, Kaplan-Meier survival analysis, and receiver operating characteristic (ROC) analysis. Pre- and post-transplant PD-L1 levels were negatively correlated with OS (pre: r = -0.44, p = 0.004; post: r = -0.48, p = 0.002). Patients with relapse had higher pre- and post-transplant PD-L1 levels than those without relapse (119.2 vs. 74.6 pg/mL, p = 0.01; and 184.4 vs. 63.4 pg/mL, p = 0.01, respectively). Post-transplant PD-L1 was higher in patients with graft failure than in those without graft failure (178.7 vs. 87.5 pg/mL, p = 0.008). Kaplan-Meier analysis showed poorer OS and DFS among patients with higher PD-L1 according to the study cutoffs. In conclusion, higher serum PD-L1 levels before and after ASCT were associated with adverse clinical outcomes in this cohort. Given the small sample size, limited follow-up, single-center design, and multiple unadjusted comparisons, these findings should be considered exploratory and require validation in larger studies.

PMID 42875958
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PubMedDrug testing and analysis2026-10-15

Detection of CJC-1295 in Equine Plasma by ELISA.

Timms Mark M, Cawley Adam A, Steel Rohan R

CJC-1295 is a peptide-based drug that stimulates the endogenous production of growth hormone (GH). Compared to other growth hormone releasing hormone (GHRH) analogues, CJC-1295 has an extended half-life due to a drug affinity complex (DAC) that chemically crosslinks the peptide to plasma proteins containing free cysteine residues. As a result, CJC-1295 behaves more like a protein doping agent than a typical peptide-based drug. Using monoclonal antibodies raised against the CJC-1295 peptide, an ELISA was developed for the detection of CJC-1295 protein conjugates in equine plasma at concentrations as low as 12.5 pg/mL. The effectiveness of the assay for controlling the illicit use of CJC-1295 was demonstrated using equine blood samples, obtained from thoroughbred racehorses, following subcutaneous administration of 10 mg of CJC-1295.

PMID 42876013
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