CTDCommons is a free, public archive of complete IND submission packages donated by biotech sponsors and contributed by open-science researchers. Every dossier is real, every module is intact, and every page is searchable — built for regulatory professionals who need the actual artifact, not a template.
Allena Pharmaceuticals, Inc. · Hyperuricemia in patients with gout · Oral engineered urate oxidase
Donated by Lumen Bioscience
Phase 1 IND for an engineered uricase targeting hyperuricemia and gout in chronic kidney disease patients. A useful reference for first-in-human dosing strategy and CMC for an engineered protein therapeutic.
Allena Pharmaceuticals, Inc. · Hyperoxaluria and recurrent calcium oxalate kidney stones · Oral recombinant oxalate decarboxylase
Donated by Lumen Bioscience
IND for an oral recombinant enzyme treating enteric hyperoxaluria. Instructive for sponsors developing oral biologics — non-systemic delivery, GI-tract pharmacology, and enzyme stability data are all atypical for Module 3.
Broad Institute of MIT and Harvard · Eric Minikel, sponsor representative · Symptomatic prion disease · Divalent siRNA (small interfering RNA)
Contributed by Eric Minikel · source
Research IND for a divalent siRNA targeting prion disease in symptomatic patients. Cleared by FDA in March 2025. The 92-document submission includes the full IND plus Pre-IND Type B and Type D meeting correspondence — a rare public look at the dialogue between sponsor and FDA before clearance.
Companion paper: Divalent siRNA for prion disease · Nucleic Acids Research · doi:10.1093/nar/gkag287
Released under CC-BY-4.0
Field guides drawn from the dossiers themselves — what the FDA's language really means, and what a decade of regulatory dialogue actually looks like.
Regulatory affairs leads at small and mid-size biotechs preparing first-in-human INDs benchmark cover letters, Module 2 summaries, and CMC narratives against real cleared submissions instead of generic templates.
Independent regulatory consultants use CTDCommons as a working reference library when advising sponsors on submission structure, FDA correspondence patterns, and modality-specific filing precedent.
Regulatory affairs fellows and trainees learn the eCTD format from real, complete dossiers — the kind of artifact you cannot get from a textbook or a course.
Every dossier in CTDCommons is a real IND submission package — either donated by the original sponsor or contributed by a sponsor-investigator with publication rights. Nothing is synthetic, reconstructed from secondary sources, or redacted beyond what the contributor required.
Open regulatory data accelerates research, especially for rare and neglected diseases. CTDCommons exists to give first-time IND sponsors something better to learn from than blank templates, and to give researchers and patient advocates a window into what FDA submission actually looks like.
Regulatory affairs leads at small and mid-size biotechs preparing first-in-human INDs, independent regulatory consultants building reference libraries, regulatory affairs trainees learning the eCTD format, and researchers or patient advocates studying real FDA correspondence.
The complete eCTD package as submitted: cover letter, Module 1 administrative documents (Forms 1571, 3674), Module 2 summaries, Module 3 CMC, Module 4 nonclinical, and Module 5 clinical. Where contributors have authorized it, FDA correspondence and Pre-IND meeting materials are also included.
The Common Technical Document format organizes a regulatory submission into five modules. Module 1 holds region-specific administrative content. Module 2 contains the high-level summaries written for FDA reviewers. Module 3 covers chemistry, manufacturing, and controls. Modules 4 and 5 hold nonclinical and clinical study reports. Each dossier in CTDCommons is browsable by module so you can jump straight to the section you need.
Sponsors and sponsor-investigators interested in donating an IND can contact the CTDCommons team via ctdcommons.org. Contributions can be released under CC-BY-4.0 or under custom terms negotiated with the contributor.
CTDCommons is operated by Chrona in partnership with 1DAY SOONER and Renaissance Philanthropy. Chrona's commercial product is a regulatory document intelligence platform that helps biotechs prepare IND submissions. 1DAY SOONER and Renaissance Philanthropy support the underlying mission. Learn about the CTDCommons mission and fund at ctdcommons.org.