FDA Office of Orphan Products Development
FDA Office of Orphan Products Development sponsors 10 registered US clinical trials on ClinicalTrials.gov, none currently recruiting, and 10 completed. 0 of these trials are in Phase 3-4 (later-stage) and 8 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Neurofibromatosis 2, with 1 trials.
Trial Pipeline
10 total, page 1 of 1
A Controlled Study of Olanzapine in Children With Autism
NCT00057408
Testing of ADI-PEG in Hepatocellular Carcinoma
NCT00056992
Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine
NCT00056810
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
NCT00030043
Keratinocyte Growth Factor to Prevent Acute GVHD
NCT00031148
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
NCT00029328
Minocycline in Patients With Huntington's Disease
NCT00029874
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
NCT00027391
ADI-PEG in Patients With Metastatic Melanoma
NCT00029900
Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
NCT00004429
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 5 |
| Phase 2 | 3 |
Therapeutic Areas
What the Pipeline for FDA Office of Orphan Products Development Shows
According to the ClinicalTrials.gov registry, FDA Office of Orphan Products Development is linked to 10 US clinical trials across every stage of research activity. Of those, 0 studies are currently recruiting, about 0% of the sponsor's indexed portfolio, and 10 are already marked complete, representing roughly 100% of the total.
The phase mix for FDA Office of Orphan Products Development reports 0 late-stage studies (Phase 3 and Phase 4 combined) and 8 earlier-phase studies (Phase 1 and Phase 2).
The top therapeutic focus area indexed for FDA Office of Orphan Products Development is Neurofibromatosis 2 with 1 linked trial, and 0 other condition areas appear in the top list above.
How to read these pipeline numbers
Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.
A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.
That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.