Lanifibranor (IVA-337) is an oral pan‑PPAR agonist entering Phase 3 trials for metabolic dysfunction‑associated steatohepatitis (MASH/MASLD). The molecule was optimized from high‑throughput screening and its preclinical data were published in the Journal of Hepatology in June 2025. Inventiva Pharma is leading development, positioning lanifibranor as a potential first‑in‑class therapy that simultaneously activates PPAR‑α, β/δ, and γ. The trial aims to demonstrate histologic improvement and fibrosis regression in patients with advanced liver disease.

In 2025 the FDA approved fifteen novel large‑molecule therapies, representing 33 % of all new drug approvals that year. The slate was dominated by oncology biologics, including five antibody‑drug conjugates and bispecific antibodies, while non‑cancer indications saw first‑in‑class agents for hereditary...

Drug Hunter’s December 2025 patent roundup spotlights four high‑impact filings: Dark Blue Therapeutics’ MLLT1/3 degraders, Insilico Medicine’s KRAS(G12V) inhibitors with demonstrated in‑vivo efficacy, Biohaven’s TRPM2 antagonists for pain, and Rome Therapeutics’ LINE‑1 reverse‑transcriptase prodrugs for oncology. These disclosures reflect rapid...

Drug‑induced liver injury (DILI) now accounts for roughly 22 % of safety‑related clinical trial failures and one‑third of post‑approval market withdrawals, making it a critical bottleneck in pharmaceutical development. The blog highlights three recent de‑risking efforts: BMS’s LPA1 antagonist program that...

The post outlines core principles of ligand‑target binding essential for drug discovery, emphasizing how small molecules engage protein sites. It highlights the interplay of binding kinetics, thermodynamics, and inhibition mechanisms in shaping potency. The author explains how affinity can be...

In 2025 the FDA approved 31 novel small‑molecule drugs, representing 67% of all new drug launches and a slight decline from the previous year. Oncology dominated the portfolio with nine approvals, while 29% were first‑in‑class therapies and 22% received accelerated...
Ziftomenib (Komzifti®), an oral menin‑KMT2A inhibitor, received FDA approval in November 2025 for adults with relapsed or refractory acute myeloid leukemia (AML) harboring NPM1 mutations. The drug blocks the menin‑KMT2A protein interaction, disrupting leukemogenic transcription programs. In the Phase 1/2 KOMET‑001...
Cytokinetics’ aficamten (Myqorzo®) received FDA approval as an oral cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy (oHCM). The drug is a next‑generation, reversible, allosteric inhibitor designed to simplify dose‑titration compared with the existing agent mavacamten. In a Phase 3 trial, aficamten...
In July 2025, the FDA granted approval to delgocitinib (Anzupgo®), a topical pan‑JAK inhibitor, for adult chronic hand eczema unresponsive or unsuitable for corticosteroids. Developed by Japan Tobacco and Leo Pharma, the formulation delivers the drug directly to affected skin,...
Alcon, Aerie Pharmaceuticals, and Avizorex Pharma announced FDA approval of acoltremon (Tryptyr®), the first‑in‑class TRPM8 thermoreceptor agonist for dry eye disease. The ophthalmic solution activates corneal nerves to boost natural tear production, offering a novel mechanism compared with existing anti‑inflammatory...
Treosulfan (Grafapex®) received FDA approval in 2025 when combined with fludarabine as a conditioning regimen for allogeneic stem‑cell transplantation (alloHSCT) in patients aged one year and older with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The approval follows trials...
Camizestrant is an oral, selective estrogen‑receptor‑alpha (ERα) degrader developed by AstraZeneca for ER‑positive, HER2‑negative, ESR1‑mutated breast cancer. The drug advanced to a Phase 3 trial, with results published in the New England Journal of Medicine in June 2025. The study demonstrated a...

Drug Hunter’s 2025 resource roundup highlights the ten most accessed tools that support daily drug‑discovery workflows. The suite includes practical PK calculators, bioisostere and covalent inhibitor cheat sheets, a searchable structure and patent database, and a series of 25 Flash...

Researchers have unveiled a novel class of translation‑inhibiting interdictors that selectively suppress MYC protein production, offering a viable strategy to target MYC‑driven malignancies. These small‑molecule agents disrupt the initiation of mRNA translation, leading to rapid depletion of MYC levels in...

2025 drug discovery emphasized rigorous target selection, with genetics‑driven programs outpacing unvalidated approaches. Immunology saw a breakthrough as small‑molecule degraders and inhibitors of transcription factors IRF5 and STAT6 demonstrated oral activity, challenging the dominance of biologics. Emerging modalities such as...

The article reviews the role of the neonatal Fc receptor (FcRn) in extending IgG half‑life and outlines how therapeutic blockade of this pathway can reduce pathogenic antibodies in autoimmune diseases. It surveys the currently approved FcRn‑targeting biologics, such as efgartigimod...
Zoliflodacin (ETX-0914) received FDA approval as an oral bacterial type II topoisomerase inhibitor for the treatment of urogenital gonorrhea. The drug emerged from rational design of earlier inhibitors and is the product of a partnership among AstraZeneca, Entasis, Innoviva and GARDP....

2025 proved pivotal for drug discovery, with the FDA approving 44 new therapies and several breakthrough candidates advancing to late‑stage trials. The most‑read case studies highlighted oral macrocycles, innovative PK engineering, and first‑in‑class modalities such as the pan‑RAS glue daraxonrasib...
Gepotidacin (Blujepa®), an oral bacterial type II topoisomerase inhibitor developed by GSK, received approval in April 2025 for uncomplicated urinary‑tract infections and gonorrhea. The drug emerged from an unbiased antibacterial screening program and represents the first new oral class of antibiotics targeting...

The November 2025 Patent Highlights post serves as a gateway to Drug Hunter’s most‑read resources, including top‑10 lists of popular articles, reviews, and case studies from the year. It spotlights a detailed review of FcRn biology and the push toward oral...

The article reviews the NLRP3 inflammasome inhibitor DFV890, highlighting its Phase 2 data in acute coronary syndrome and its mechanism of selectively blocking NLRP3 activation. It also examines emerging NLRP3‑targeted programs, including covalent inhibitors and PROTAC degraders, and discusses the broader...
Springworks Therapeutics and Pfizer announced FDA approval of mirdametinib (PD0325901), an oral, brain‑penetrant MEK1/2 inhibitor for treating neurofibromatosis type 1‑associated plexiform neurofibromas (NF1‑PN) in both adults and children. The drug was optimized from an earlier in‑vitro tool compound to improve potency...
Fenebrutinib (GDC‑0853) is an oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor that entered Phase 3 trials for multiple sclerosis in a November 2025 press release. The drug was discovered through ATP‑site‑directed compound library screening and subsequently optimized by Roche and Genentech. Its...

The article reviews patenting strategies for small‑molecule drugs, emphasizing the need for early and comprehensive protection. It outlines the typical patent lifecycle—from provisional filings through PCT applications to national‑phase prosecution—and the legal standards of utility, novelty, and non‑obviousness. Real‑world examples...

The article presents a comprehensive list of pharmaceutical salts that can be leveraged to enhance the taste, solubility, and overall patient acceptability of oral drug formulations. It outlines the physicochemical properties, regulatory status, and typical applications of both traditional inorganic...