Today in Pharmacology

Key 2026 updates: four new standardised acute-exacerbation flowcharts for primary care and ED; epinephrine-first rule when anaphylaxis co-exists; new assessment tools (CAAT, Peds-AIRQ, PRAM); OCS stewardship priority; updated vaccine evidence (influenza, RSV, COVID-19). Track 1 ICS-formoterol AIR/MART remains the preferred treatment approach at all steps for adults and adolescents.

Major 2026 changes: LDL-C and non-HDL-C absolute goals reinstated alongside % reduction targets; PREVENT™ equations replace Pooled Cohort Equations for ASCVD risk; Lp(a) measured at least once in all adults; inclisiran (siRNA) and bempedoic acid receive expanded recommendations; olezarsen (ApoC-III ASO) added for FCS with TG ≥ 1000 mg/dL. LDL-C goal <55 mg/dL for very high-risk ASCVD.

UK multi-specialty consensus from acute medicine, neurology, ICU and emergency medicine. Five-stage timed algorithm: lorazepam rescue → levetiracetam/valproate/phenytoin at 15–30 min → propofol/midazolam sedation at RSE → tertiary neurocritical care for SRSE. Includes updated MHRA 2024 valproate restrictions, full ASM doses, ICU sedation table (propofol, midazolam, thiopentone, ketamine), and autoimmune SE management.

The Indian government has tightened regulatory controls on pregabalin, a gabapentinoid used for neuropathic pain, fibromyalgia, and epilepsy, in response to rising reports of recreational misuse and diversion. The move strengthens Schedule H1 enforcement requirements, including mandatory recording of prescriptions and tighter pharmacist compliance.

The Central Drugs Standard Control Organisation (CDSCO) released its latest Not of Standard Quality (NSQ) alert listing 169 drug samples that failed quality testing across multiple parameters, with one sample declared spurious — a significant concern for patient safety. The alert covers a range of common medicines including antibiotics, vitamins and cardiovascular drugs.

The Indian Council of Medical Research (ICMR) has introduced a unified single-window clearance system for medical research studies, replacing the previous fragmented multi-committee approval process. The reform aims to streamline ethics committee review, reduce duplication, and accelerate the regulatory pathway for clinical trials and observational studies conducted in India.

The US FDA has granted Priority Review designation to Zydus Lifesciences' saroglitazar magnesium — a dual PPARα/γ agonist already approved in India for diabetic dyslipidaemia — for the treatment of non-alcoholic steatohepatitis (NASH). Priority Review shortens the FDA's review timeline from 10 months to 6 months, marking a significant milestone for an Indian-origin drug seeking a major US indication.

TRIUMPH-1 (n = 2,339; 80 weeks) tested the first-in-class GIP/GLP-1/glucagon triple receptor agonist retatrutide at three doses (4 mg, 9 mg, 12 mg) versus placebo in adults with obesity or overweight and at least one comorbidity, without diabetes. At the highest 12 mg dose, participants lost a mean 28.3% of body weight (−70.3 lbs); 45.3% achieved ≥30% weight loss versus 0.5% on placebo. A 104-week extension subset (12 mg, n = 532, BMI ≥35) reached 30.3% weight loss, with 65.3% achieving BMI <30. Secondary endpoints showed reductions in waist circumference (−9.5 cm), non-HDL cholesterol, triglycerides, systolic BP (−14 mmHg), and hsCRP. The most common adverse events were GI (nausea 42.4%, diarrhoea 32.0%); a dysesthesia signal was noted (12.5% vs 0.9% placebo). Discontinuation due to AEs was 11.3% vs 4.9%.

Parallel-group RCT (n = 118; mean age 68 yrs, BMI ~34) at 2 UK hospitals. Older persistent AF patients (BMI ≥ 27) undergoing cardioversion randomised to 8-month structured low-calorie diet vs. usual care. Primary endpoint — AFSS symptom severity score (8 months): 7.9 vs. 8.9 (difference −0.9; 95% CI −3.3 to 1.4; P = 0.43 — non-significant). Despite real weight loss (9.7% vs. 3.1%; −6.9 kg; P < 0.001, sustained at 3.5 years), no benefit on AF burden (P = 0.58), AF recurrence (HR 1.04; P = 0.85), cardiac MRI remodelling, blood pressure, lipids, hsCRP, IL-6, or NT-proBNP. No serious adverse events. Challenges current Class I guideline recommendations for weight loss in AF — effect may be limited in older patients with established atrial remodelling.

Montelukast (Singulair), a widely-prescribed leukotriene receptor antagonist used for asthma and allergies, blocks CysLTR1 — a molecule tumours exploit to suppress neutrophil-mediated immune responses. Preclinical studies in mouse models of triple-negative breast cancer, melanoma, ovarian, colon, and prostate cancer showed slowed tumour growth, restored immune attack, and improved survival when combined with checkpoint immunotherapy. Rapid translation to clinical trials is feasible given existing FDA approval.

Dr. Reddy's Laboratories launched Obeda, India's first oral semaglutide biosimilar tablet, at ₹99/pill — a fraction of the cost of Novo Nordisk's Rybelsus. CDSCO-approved following a Phase III trial in 288 Indian patients with type 2 diabetes, demonstrating non-inferior efficacy and comparable safety to the innovator product. The launch follows the company's earlier generic semaglutide injections in India and Canada, consolidating Dr. Reddy's GLP-1 portfolio amid global demand for affordable weight-management and diabetes therapies.

Two replicate phase 3 double-blind RCTs (TETON-1: n = 598; TETON-2: n = 593) randomised IPF patients with FVC ≥ 45% predicted to inhaled treprostinil (prostacyclin IP-receptor agonist) or placebo over 52 weeks. Primary endpoint — FVC change at 52 weeks: TETON-1 placebo-corrected difference +130.1 mL; TETON-2 treprostinil −49.9 mL vs. placebo −136.4 mL (+95.6 mL; P < 0.001). Pooled: +111.8 mL. Clinical worsening (death / respiratory hospitalisation / ≥10% FVC decline): 27.2% vs. 39.0% (HR 0.71; 95% CI 0.53–0.95; P = 0.02). Adverse events: cough 48.3% vs. 24.1%; discontinuation 33.6% vs. 24.7%. Treprostinil (approved for PAH as Tyvaso) now demonstrates antifibrotic benefit beyond its vasodilatory mechanism.

New Drugs & Clinical Trials Amendment Rules, 2026 — notified 20 January, in force 6 March 2026. Approval timelines halved from 90 to 45 working days. Prior Intimation pathway introduced for BA/BE studies and non-clinical manufacturing, replacing mandatory prior approval for eligible drug categories. 12 rules amended, 2 fully substituted, forms CT-10/CT-12/CT-13 updated.

The full text of the New Drugs & Clinical Trials (Amendment) Rules, 2026 as published in The Gazette of India (Extraordinary). G.S.R. 46(E), notified by the Ministry of Health & Family Welfare on 20 January 2026. Bilingual (Hindi & English), 9 pages — read and download the official document.

Over 600 fixed-dose combinations banned in India since 1983 — from the foundational Amidopyrine ban to the 156-FDC August 2024 order and 35 more in April 2025. A decade-by-decade analysis covering the Kokate Committee, the 2016 mega-ban, Saridon & Corex withdrawals, and the ongoing antimicrobial stewardship push.

A 2020 Springer Nature review on hantavirus pharmacotherapy. Ribavirin reduces HFRS mortality by 83% (IV, early) but is ineffective for HPS/Sin Nombre virus. Favipiravir shows promise in animal models for New World hantaviruses. Vandetanib (VEGFR-2 inhibitor) reduces vascular permeability. Convalescent plasma benefits Andes virus HPS. Vaccines span three generations: Hantavax (1st-gen, licensed Korea/China), recombinant VLPs (2nd-gen, trials), and GLS-5700 DNA vaccine (3rd-gen, Phase I completed).

A comprehensive 2018 Elsevier review covering the full landscape of anti-Ebola pharmacology: entry inhibitors (tetrandrine EC50 = 55 nM; toremifene 50% mouse survival; clomiphene 90% mouse survival), mAb cocktails (ZMapp 100% NHP survival; MB-003 75% human survival), replication inhibitors (remdesivir/GS-5734 — 100% NHP survival, 5/7 macaques protected 3 days post-infection; favipiravir JIKI trial), and budding inhibitors (imatinib, nilotinib via Abl kinase/VP40 pathway).