Simulations Plus offers modeling and simulation software and consulting across discovery and development. Its public software portfolio includes GastroPlus, MonolixSuite, and QSP tools. Modeling choices and validation should follow the intended scientific question.
Profile review: 2026-11-04 · Fields retain their individual source dates. Undisclosed values are not zero; early or historical events do not establish the latest financing. Awards and acquisitions are distinguished from equity rounds.
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Technology, programs & evidence
Simulations Plus offers modeling and simulation software and consulting across discovery and development. Its public software portfolio includes GastroPlus, MonolixSuite, and QSP tools. Modeling choices and validation should follow the intended scientific question.
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Cleveland Clinic reported that the Phase 3 Lp(a)HORIZON trial found no reduction in major cardiovascular events with the antisense drug pelacarsen after median follow-up of 4.7 years. Event rates were 12.3% with pelacarsen and 12.1% with placebo, despite substantial Lp(a) lowering. The findings concern patients with established cardiovascular disease and do not settle outcomes for other Lp(a)-lowering modalities.
European Journal of Drug Metabolism and Pharmacokinetics
A study in European Journal of Drug Metabolism and Pharmacokinetics modeled subcutaneous aqueous progesterone using single-dose crossover data from 50 healthy Chinese postmenopausal women. Machine-learning approaches screened potential covariates before conventional PopPK evaluation. Height and body-weight effects remained statistically identifiable but had limited clinical significance. Simulated repeated-dose exposure is model-derived, rather than an observed efficacy outcome in fertility patients.
On November 5, PharmaIN reported conference findings from PHIN-001: 12 participants with Child-Pugh B cirrhosis received PHIN-214; 10 completed 28 days. The issuer described Grade 1–2 treatment-related adverse events and exploratory renal, hemodynamic and PK findings. The ongoing small Phase 1 study does not establish clinical benefit. This is a company conference announcement, not a peer-reviewed paper.
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