Category: Drug development

Despite undergoing early-phase clinical trials in the early 2000s, trodusquemine is an investigational drug that is **not approved by the FDA and cannot be purchased for human consumption in the USA**. Its development was halted due to financial difficulties, and though research continues under new sponsors, it remains a substance strictly for research purposes.

According to the American Heart Association, many individuals with hypertension struggle with medication adherence, a major factor in poor blood pressure control. An investigational RNA interference (RNAi) therapy, zilebesiran, is garnering attention as the potential **six monthly blood pressure injection**, offering a novel approach to address this challenge by providing long-lasting blood pressure reduction.

The voluntary withdrawal of Lumigan 0.03% bimatoprost ophthalmic solution in 2012 puzzled many patients, especially since the drug had proven effective in treating glaucoma. This decision by manufacturer Allergan was not due to a recall or safety issues but was instead a strategic move to focus exclusively on a more advanced, and better-tolerated, formulation. The development of the 0.01% solution offered the same efficacy with a lower incidence of a common side effect.

In pharmacology, the term 'delta' can refer to various metrics, often representing a change or difference between two measured values, such as the change in a biomarker level or the difference in drug effect between two groups. Understanding whether a high or low delta is better depends entirely on the specific context and the desired outcome of the medication or intervention.

The acronym 'OBD' in pharmacology has no single, universal meaning and can refer to a specific antibiotic or a technical concept in oncology drug development. This ambiguity requires clarification to distinguish between a brand-name antibacterial medication and the 'Optimal Biological Dose' used in cutting-edge cancer research.

According to research, nearly 90% of new chemical entities in the drug development pipeline are poorly water-soluble, creating a significant challenge for effective oral medication. To address this, the full form of ASD in pharma most commonly refers to **Amorphous Solid Dispersion**, a sophisticated formulation strategy that improves drug performance and bioavailability.

With only about 10% of new drug candidates in preclinical development successfully reaching the market, the importance of a robust development process cannot be overstated. This is where the crucial field of F&D, or Formulation and Development, steps in, translating a discovered drug molecule into a patient-ready medicine.

According to the U.S. Food and Drug Administration (FDA), there are over 20,000 distinct prescription drug products available for marketing in the United States, yet this number is a moving target and represents a much more complex reality than a single count can capture. Understanding how many approved drugs are on the market requires distinguishing between active ingredients and the numerous product variations available.

Studies show that approximately 90% of all new drugs that enter clinical trials ultimately fail to gain FDA approval, highlighting the high-risk nature of pharmaceutical development [1.2.1, 1.2.3, 1.2.5]. This article explores what the FDA approval rate for drugs is and the factors that influence it.

Despite completing early-stage clinical trials for conditions like diabetes and obesity, the experimental drug trodusquemine remains unavailable for human medical use. Its availability is restricted exclusively to laboratory research purposes, preventing its acquisition for personal health treatment.