Leadiant Biosciences, Inc.
Also known as: Leadiant Biosciences, Inc | Leadiant Biosciences, Inc. | LEADIANT BIOSCI INC | Sigma Tau | SIGMA TAU | Sigma Tau HealthScience LLC | sigma-tau i.f.r. S.p.A. | Sigma-Tau Pharmaceuticals | Sigma-Tau Research, Inc. | Sigma Tau Research Switzerland SA | Sigma-Tau SpA
Highest phase reached
Phase 3
First clinical trial
Dec 1, 1999First marketed drug
Jul 22, 1969First NDA
Jul 22, 1969Last known activity
May 27, 2024
Timeline
1950s
- Jul 1, 1957
Leadiant Biosciences, Inc.— Founded
1980s
- Dec 27, 1985
levocarnitine— NDA Organization
- Dec 27, 1985
levocarnitine— NDA Secondary Org
2010s
- Oct 5, 2018
elapegademase-lvlr— Marketing Organization
Drugs by trial phase (48 distinct, 39 trials)
Phase 3 (8 own, 0 via acquisition)
Phase 2 (28 own, 0 via acquisition)
Phase 1 (9 own, 0 via acquisition)
Other trials (3 own, 0 via acquisition)
Indications
Approved for
Studied for
- Atrophy
- Breast Neoplasms
- Colitis
- Colitis, Ulcerative
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Digestive System Neoplasms
- Distal Myopathies
- Enterocolitis
- Enterocolitis, Necrotizing
- Essential Hypertension
- Fatigue
- Gastrointestinal Neoplasms
- Glioma
- Head and Neck Neoplasms
- Heart Failure
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Hepatitis, Chronic
- Hypertension
- Immunologic Deficiency Syndromes
- Intermittent Claudication
- Kidney Diseases
- Kidney Failure, Chronic
- Leukemia
- Leukemia, Lymphoid
- Liver Neoplasms
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Malaria
- Malaria, Falciparum
- Malaria, Vivax
- Melanoma
- Multiple Myeloma
- Muscular Atrophy
- Muscular Atrophy, Spinal
- Muscular Diseases
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Plasma Cell
- Pancreatic Neoplasms
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Polyneuropathies
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Respiratory Tract Neoplasms
- Severe Combined Immunodeficiency
- Skin Neoplasms
- Soft Tissue Neoplasms
- Spinal Muscular Atrophies of Childhood
- Ulcer
- Urogenital Neoplasms
- Varicose Ulcer
- Vascular Diseases
Marketed drugs (8)
Recent trials (42)
- NCT06260748Lead sponsorPhase 3May 27, 2024
- NCT04231266CollaboratorPhase 2Feb 1, 2020
- NCT03188328Lead sponsorPhase 1Jun 1, 2017
- NCT02602067Lead sponsorPhase 1Nov 1, 2015
- NCT02110784Lead sponsorPhase 2Jun 18, 2014
- NCT02043587CollaboratorPhase 2Jan 1, 2014
- NCT01954017Lead sponsorPhase 1/Phase 2Dec 1, 2013
- NCT01420627Lead sponsorPhase 3Dec 1, 2013
- NCT02053324Lead sponsorPhase 1Nov 11, 2013
- NCT01992900Lead sponsorPhase 2Nov 1, 2013
- NCT01878708CollaboratorEarly Phase 1Jul 1, 2013
- NCT01764880Lead sponsorPhase 1Nov 1, 2012
- NCT01855373CollaboratorN/AJul 1, 2012
- NCT02229721CollaboratorPhase 2Jun 1, 2012
- NCT01567956Lead sponsorPhase 3Apr 1, 2012
Details
- Founded
- Vico Nel Lazio, IT Jul 1, 1957
- First NDA
- Jul 22, 1969
- Last known activity
- May 27, 2024
Designations held
- Orphan drug
- Fast track
- Priority review
Notes
--- Pre-folding founded info: 1980-06-01 Gaithersburg MD US https://www.crunchbase.com/organization/sigma-tau#section-overview ---