Abstract

India faces a growing burden of type 2 diabetes mellitus (T2DM), necessitating innovative treatments that improve glycemic control, reduce glycemic variability (GV), and enhance patient adherence. Dipeptidyl peptidase 4 (DPP-4) inhibitors are established antidiabetic agents; however, once- or twice-daily dosing often limits long-term compliance. Trelagliptin, a novel once-weekly DPP-4 inhibitor, addresses this issue with an extended half-life and superior molecular stability, enabling sustained DPP-4 inhibition and significant GV reduction. Improved glycemic control with trelagliptin can potentially lower the risk of macrovascular and microvascular complications associated with T2DM. Trelagliptin, developed and launched in India by Zuventus Healthcare Limited under the brand name Trelaglip® , offers prolonged efficacy and high selectivity in inhibiting the DPP-4 enzyme, helping minimize side effects. Development began with in-house active pharmaceutical ingredient (API) synthesis, followed by successful formulation and stability studies. A bioequivalence study confirmed pharmacokinetic equivalence with the reference product by Takeda, Japan. In a randomized phase 3 clinical trial involving patients with glycated hemoglobin (HbA1c) ≥8%, trelagliptin showed greater HbA1c reduction (−1.25%) as compared to vildagliptin (−1.15%) and a similar safety profile. Mild adverse events occurred in 6.67% of trelagliptin users compared to 9.17% with vildagliptin. This article outlines the development and regulatory journey leading to trelagliptin’s first approval in India by the Central Drugs Standard Control Organization (CDSCO) in December 2024. Phase 4 real-world evidence studies are currently ongoing in India to assess long-term safety and efficacy.

Abstract

Background

One of the most significant postoperative challenges faced by patients is the occurrence of acute episodes of pain and inflammation, often accompanied by the development of edema, particularly in the case of large wounds. Consequently, any delay in the healing process of such wounds can exert a substantial impact on recovery. This delay can potentially be mitigated by addressing the moisture imbalance at the wound site using proteases, while concurrently minimizing pain and inflammation through the use of appropriate analgesic and anti-inflammatory preparations. The objective of this study was to evaluate the safety and efficacy of Tibrolin® D, a fixed-dose combination comprising trypsin, bromelain, rutoside, and diclofenac tablets, in alleviating pain intensity and enhancing wound healing in patients experiencing acute pain resulting from uncontaminated minor orthopedic surgical procedures or wounds.

Method

An open-label, multicenter, controlled, comparative Phase IV clinical study was conducted on 200 patients who underwent elective, clean, and uncontaminated minor orthopedic surgery. These patients were randomized (1:1) to receive either Tibrolin® D (a combination of trypsin 48 mg, bromelain 90 mg, rutoside 100 mg, and diclofenac 50 mg) or Voveran® 50 GE (diclofenac 50 mg) as one tablet orally, thrice a day postoperatively for seven days. The primary outcome was the proportion of patients reporting adverse events. Secondary outcomes included a total wound symptom score, evaluated based on symptoms after minor orthopedic surgery using a four-point Likert scale, and pain intensity assessed by the Numerical Pain Rating Scale.

Results

No adverse events were observed in this study. Both groups demonstrated statistically significant improvement (p < 0.001) in all assessed wound symptoms: erythema, edema, discharge, induration, local irritation, tenderness, and pain. By Day 7, total wound symptom scores significantly decreased in both the Tibrolin® D group (12.84 ± 2.89 to 2.24 ± 2.08) and the diclofenac group (12.86 ± 3.29 to 2.66 ± 2.28) (p < 0.001), with no significant difference between groups (p = 0.318). Pain intensity also decreased significantly in both groups by Day 7 (p < 0.001), with no significant difference in mean change between groups (p = 0.412). Notably, 91% of patients and 96% of investigators rated Tibrolin® D as good to excellent in relieving wound symptoms, comparable to ratings for diclofenac (88% and 96%, respectively).

Conclusion

Tibrolin® D was as well tolerated as diclofenac, indicating a favorable safety profile. The findings also suggest that Tibrolin® D improves wound healing symptoms and reduces pain intensity following minor orthopedic surgeries, demonstrating efficacy comparable to diclofenac.

The combination of Levodropropizine and Chlorpheniramine Maleate offers a dual-action approach for the symptomatic relief of cough and allergic components in upper respiratory tract infections.

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Abstract

Background

Trelagliptin and vildagliptin are oral dipeptidyl peptidase-4 (DPP-4) inhibitors used in the treatment of type 2 diabetes mellitus. The administration of vildagliptin is twice daily, whereas trelagliptin provides the convenience of once-weekly dosing, which may enhance patient adherence. A phase 3 clinical trial was conducted to assess the non-inferiority of trelagliptin compared to vildagliptin.

Methods

This multicenter, randomized, open-label, parallel-group, active-controlled non-inferiority clinical trial was conducted at 10 geographically distinct sites across India. A total of 240 treatment-naive patients with type 2 diabetes mellitus were randomized in a 1:1 ratio to receive either trelagliptin (100 mg once weekly) or vildagliptin (50 mg twice daily) for 16 weeks. The primary endpoint was non-inferiority of trelagliptin to vildagliptin in reducing glycated hemoglobin (HbA1c) levels from baseline to week 16. Secondary efficacy measures included changes in fasting and postprandial blood glucose, fasting insulin, glucagon, C-peptide, and glucagon-like peptide-1 (GLP-1) levels. Safety was assessed based on the incidence of adverse events.

Results

At week 16, the mean HbA1c levels were 7.18 ± 1.47% and 7.21 ± 1.49% in trelagliptin and vildagliptin groups, respectively (Δ -0.89% vs. Δ -1.00%, p < 0.0001). The difference between groups was 0.11% (95% CI: -0.28 to 0.50; p = 0.5899), showing non-inferiority of trelagliptin. A total of 48.57% of patients in the trelagliptin group and 47.57% in the vildagliptin group achieved the target HbA1c level of <7% (p = 0.8850). No statistically significant differences were observed between the groups for glycemic parameters, including fasting blood glucose (Δ 1.11; 95% CI: -16.79 to 19.02; p = 0.9025), 2-hr postprandial glucose (Δ 3.33; 95% CI: -30.55 to 23.88; p = 0.8093), fasting serum insulin (Δ 5.22; 95% CI: -15.01 to 25.45; p = 0.6113), fasting glucagon (Δ 0.72; 95% CI: -96.34 to 94.90; p = 0.9882), C-peptide (Δ 0.36; 95% CI: -0.31 to 1.03; p = 0.2912), and GLP-1 levels (Δ -0.02; 95% CI: -0.06 to 0.02; p = 0.3995). All reported adverse events were mild in nature and resolved without any lasting effects. Adverse events occurred in 6.67% (8/120) of patients in the trelagliptin group and 9.17% (11/120) in the vildagliptin group.

Conclusions

Trelagliptin showed a significant reduction in HbA1c, fasting, and postprandial glucose levels, indicating effective glycemic control in patients with type 2 diabetes mellitus. The study drug exhibited a favorable safety profile, with no major adverse events reported. Overall, trelagliptin proved to be both efficacious and well-tolerated, demonstrating non-inferiority to vildagliptin.

Plecasoft contains the active ingredient plecanatide, which works directly in the intestine to help increase fluid and support regular bowel movements. It acts like a natural substance in your body to draw water into the intestines, making stools softer and easier to pass. This makes stools softer and easier to pass. It helps relieve symptoms like hard stools, bloating, and stomach discomfort. Plecasoft is used in adults to treat long-term(chronic) constipation and constipation caused by irritable bowel syndrome (IBS-C).

The combination of ‘Pregabalin and Duloxetine’ is an emerging, fast-growing therapy for Painful Peripheral Neuropathy associated with Mood Disorders. Upnuron-D, offers enhanced efficacy in relieving neuropathic pain while helping regulate mood. Upnuron-D, provides patients with effective pain relief and mood stabilization, promoting overall well-being.

Topical Pregabalin 8% is an emerging therapy for Diabetic Neuropathic Pain. This targeted formulation is designed to reduce pain while minimizing adverse effects. Reperi Gel, provides patients with an effective solution that manages discomfort and minimizes systemic side effects, helping them lead a more comfortable life.

Bevon-NH is a comprehensive blend of essential multi-vitamins, minerals, and antioxidants formulated to ensure well-being of Nerve Health. Bevon-NH, helps alleviate symptoms of Nutritional Deficiency & Diabetic/ Peripheral Neuropathy. By addressing Nerve-related discomfort, Bevon-NH not only relieves pain but also promotes holistic wellness.