Sold as Pizensy. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Lactitol (sold as Pizensy), first approved Feb 12, 2020, with 0 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate CancerProstate Cancer, Prostatic Neoplasms · Lithuanian University of Health Sciences | — | Recruiting | Oct 7, 2026 |
| Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation) · Novartis Pharmaceuticals | Phase 2 | Not yet recruiting | Jul 1, 2026 |
| Comparing Migraine Preventive Therapies vs. Anti-CGRP Therapies for Tinnitus in Patients With Migraine (COMPACT-PM)Migraine Associated Vertigo, Tinnitus · Stanford University | Phase 4 | Not yet recruiting | Jun 17, 2026 |
| A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 SkippingMuscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy) · Avidity Biosciences, Inc. | Phase 3 | Recruiting | May 14, 2026 |
| Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study TreatmentsLocally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation · Novartis Pharmaceuticals | Phase 1 / Phase 2 | Active, not recruiting | Mar 12, 2026 |
| Remibrutinib Open Label Roll-over Post-trial Access ProtocolIndication of the Parent Protocol · Novartis Pharmaceuticals | Phase 3 | Recruiting | Mar 9, 2026 |
| LE + CC vs. LE for Ovulation InductionLetrozole, Clomiphene Citrate · Mỹ Đức Hospital | Not applicable | Recruiting | Apr 18, 2025 |
| A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With MyelofibrosisIntermediate- and High-risk Myelofibrosis (MF) Patients With Splenomegaly · Suzhou Junjing BioSciences Co., Ltd. | Phase 1 / Phase 2 | Active, not recruiting | Apr 3, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 12, 2020 | PizensyNDA 211281 · New molecular entity | Braintree Labs | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
