AltaThera’s scientific programs are built on a simple premise: better data leads to better medicine. By applying advanced pharmacometric modeling to existing human clinical data, we optimize how therapies are delivered, identify safety signals earlier, and expand access to patients who have historically had few good options.
Model-Informed Drug Development — MIDD — uses mathematical models built from real-world clinical data to guide decisions across the drug development lifecycle. Rather than relying solely on traditional trial endpoints, MIDD uses pharmacokinetic and pharmacodynamic (PK/PD) modeling to predict how a drug will behave in a given patient, at a given dose, under specific clinical conditions.
Modeling clinical data allows us to identify the right dose for the right patient — reducing the risk of underdosing or toxicity, and enabling individualized treatment rather than one-size-fits-all protocols.
PK/PD models can identify potential adverse effects and drug interactions that may not surface in standard trials — improving patient safety before problems reach the clinic.
By leveraging existing clinical data, MIDD reduces the need for redundant trials and supports more targeted regulatory submissions — getting effective therapies to patients sooner.
AltaThera was among the first pharmaceutical companies to participate in the FDA’s MIDD Paired Meeting Pilot Program — and the results speak for themselves. In 2020, Sotalol IV earned FDA approval for the initiation, re-initiation, and dose escalation of oral sotalol therapy in adults, granted on the basis of MIDD modeling rather than traditional clinical trials. It was one of the first drugs approved under this regulatory pathway.
Our methodology doesn’t stop at a single phase of development — it spans the full lifecycle of every therapy we bring to market.
AltaThera’s scientific approach is supported by a growing body of peer-reviewed research. Key publications on the clinical performance and implementation of Sotalol IV — including the PEAKS Registry results and real-world implementation protocols — are available to be viewed →
Investigator-initiated research is a critical complement to AltaThera-sponsored programs. Independent clinical inquiry strengthens the evidence base for intravenous antiarrhythmic therapy and helps us better understand the benefits and risks of our therapies across the full spectrum of patients who need them.
If you are a physician or researcher interested in collaborating with AltaThera on an investigator-initiated study, we encourage you to reach out.
Visit clinicaltrials.gov to view active and completed studies involving AltaThera and Sotalol IV.
Sotalol IV MAY CAUSE LIFE THREATENING PROARRYTHMIA and is associated with QT interval prolongation. Please see the full prescribing information including boxed warning, precautions, and contraindications at altathera.com/sotalol-iv-pi/.