Catalent, Inc. is a holding company, which engages in the provision of delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. It operates through the following segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. The Softgel and Oral Technologies segment offers formulation, development, and manufacturing services for soft capsules or softgels, as well as large-scale production of oral solid dose forms for pharmaceutical and consumer health markets and supporting ancillary services. The Biologics segment develops and produces biologic cell-line, cell therapy, and viral vector gene therapy, formulation for parenteral dose forms, which include prefilled syringes, vials, and cartridges, and analytical development and testing services for large molecules. The Oral and Specialty Delivery segment is composed of advanced formulation of a range of technologies along with integrated downstream clinical development and commercial supply solutions. The Clinical Supply Services segment is involved in packaging, storage, distribution, and inventory management of drugs and biologics in clinical trials. The company was founded in 1933 and is headquartered in Somerset, NJ.
Clinical Trials
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0 active
Approvals
27
Total approvals
Agencies
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Regulatory bodies
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No trial phase data available
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No trial data available
- Definium Therapeutics' DT120 ODT met its primary and all key secondary endpoints in the Phase 3 Panorama trial of 245 adults with generalized anxiety disorder. - The 100-microgram dose produced a 9.8-point HAM-A reduction versus 4.7 points for placebo at Week 12, a 5.1-point placebo-adjusted difference (p<0.0001, Cohen's d=0.64). - Panorama is the second positive Phase 3 GAD study for DT120 ODT and the third positive late-stage readout overall, following Voyage in GAD and Emerge in MDD. - Definium has scheduled a pre-NDA meeting with the FDA for Q4 2026 and plans to submit its New Drug Application in the first half of 2027.
- GenSight Biologics confirmed the viral genome titer of the GS010/LUMEVOQ drug substance was within target specifications, indicating a repeatable manufacturing process transfer to Catalent. - All remaining patients for the dose-ranging REVISE study in France have been identified, with the last treatment scheduled for December 2026. - Named patient early access treatments have resumed in France, with the first early access treatment in Israel performed in July 2026. - GenSight Biologics will publish its 2026 half-year financial statement after market close on September 29, 2026.
- Codis, a global CDMO specializing in spray drying and amorphous solid dispersions, has completed its acquisition of Catalent's Nottingham, UK facility, expanding its integrated European offering. - The Nottingham site brings more than two decades of formulation and clinical supply expertise, adding oral solid dose development and small-scale commercial manufacturing to Codis' capabilities. - Combined with the commercial-scale PSD-4 spray dryer investment in Haverhill, UK, the acquisition establishes Europe's most comprehensive spray dry pathway from development to commercial intermediates and final dose forms. - The integrated network provides customers working with poorly soluble molecules a faster, lower-risk route from early development through clinical supply to commercial manufacturing.
- Rinvecalinase alfa (DM199), a recombinant human tissue kallikrein-1 protein, is being developed by DiaMedica Therapeutics for preeclampsia and acute ischemic stroke, with the preeclampsia therapeutics market projected to reach USD 3,214.3 million by 2036 at a 10.0% CAGR. - Interim Phase 2 results reported in July 2025 showed dose-dependent blood pressure reductions and no placental transfer among 28 preeclampsia participants, supporting the drug's disease-modifying potential targeting endothelial dysfunction. - DiaMedica received Health Canada clearance in March 2026 for a Phase 2 early-onset preeclampsia study and dosed the first patients in a Phase 2 fetal growth restriction trial in June 2026, while the ReMEDy2 Phase 2/3 stroke trial reached 75% enrollment in May 2026. - The FDA requested additional reproductive toxicology data in June 2026, including a new rat pharmacokinetic and activity study, which may influence the timing of a U.S. investigational new drug application for the preeclampsia program.
- Elpida Therapeutics and Catalent announced a strategic partnership to support late-phase manufacturing of an AAV9 gene therapy for Spastic Paraplegia Type 50 (SPG50), an ultra-rare neurodegenerative disorder. - The collaboration ensures continued patient access to the SPG50 therapy, with the final patient planned for treatment by the end of this year potentially marking the end of availability without this manufacturing support. - Catalent will utilize its UpTempo AAV manufacturing platform and receive exclusive manufacturing rights to Elpida's other pipeline AAV gene therapy programs. - SPG50 is caused by AP4M1 mutations and leads to cognitive impairment, epilepsy, and progressive paralysis by early adulthood if left untreated.
- Cartherics has signed an amended commercial license agreement with Catalent, enabling use of a cGMP-compliant iPSC line for manufacturing and commercializing CAR-NK cell therapies targeting cancer and endometriosis. - The US FDA has approved the licensed iPSC line as the starting cell for generating Cartherics' lead product CTH-401, which targets the tumor antigen TAG-72. - The Japanese Patent Office has granted Cartherics a second patent protecting gene-edited iPSCs incorporating its chimeric antigen receptor constructs, strengthening its global IP portfolio. - Cartherics plans to file an Investigational New Drug application in late 2026, with first-in-human trials in ovarian cancer to follow.
- Lisata Therapeutics has entered a binding term sheet to be acquired by Kuva Labs for $4.00 per share in cash, representing an 85% premium over the most recent closing price. - Stockholders will receive two additional contingent value rights worth $1.00 each, tied to certepetide milestone achievements including rights reversion from Qilu Pharmaceutical and NDA filing. - The acquisition reflects the strategic value of Lisata's clinical pipeline, particularly certepetide, which Kuva previously licensed for use with its NanoMark MR imaging platform technology. - Certepetide is currently in multiple Phase 2 trials across various solid tumors and has received Fast Track and Orphan Drug designations from regulatory authorities.
- Kincell Bio, a leading cell therapy CDMO, has promoted Lawrence "Larry" Pitcher from COO to Chief Executive Officer effective immediately. - Pitcher succeeds Mark R. Bamforth OBE, who transitions to Executive Chair after guiding the company through a successful growth phase in 2025. - The leadership change comes as Kincell Bio expands its manufacturing capabilities to support clients' cell therapy programs progressing into pivotal studies and commercial launch. - Pitcher brings extensive experience from leadership roles at Catalent, Thermo Fisher, and other major biomanufacturing companies across cell and gene therapy operations.
- Jupiter Neurosciences received FDA clearance in November 2025 to initiate a Phase 2a clinical trial of JOTROL in Parkinson's disease, marking a critical regulatory milestone for the enhanced resveratrol platform. - The company launched Nugevia, a premium longevity supplement line powered by the same JOTROL technology, targeting the consumer wellness market projected to exceed $8 trillion by 2030. - Jupiter secured up to $20 million in flexible financing from Yorkville Advisors to support the Phase 2 Parkinson's trial and accelerate commercial expansion of its dual-engine business model. - JOTROL demonstrates nine-fold higher bioavailability compared to previous resveratrol formulations and has shown compelling neuroprotective effects in established Parkinson's disease models.
- The U.S. cell and gene therapy CDMO market is projected to grow from $1.94 billion in 2025 to $10.34 billion by 2033, representing a robust 23.26% compound annual growth rate. - Recent FDA approvals of breakthrough therapies including Casgevy for sickle cell disease and Elevidys for Duchenne muscular dystrophy are driving increased demand for specialized manufacturing partnerships. - Over 2,000 ongoing clinical trials in cell and gene therapies are creating unprecedented demand for viral vectors, plasmids, and clinical-grade cell processing capabilities. - Leading CDMO players including Lonza, Catalent, WuXi Advanced Therapies, and Thermo Fisher are investing heavily in expanding manufacturing capacity to meet surging outsourcing demand.
