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Leo Pharma
Also known as: Astellas Pharma US, Inc. | LEO Innovation Lab | LEO LABS | LEO PHARM | LEO Pharma | LEO Pharma A/S | LEO PHARMA AS | LEO Pharmaceutical Products LLC | LEO Pharma GmbH, Neu-Isenburg, Germany | LEO Pharma Hellas SA | LEO Pharma Limited, Korea
Highest phase reached
Phase 4
First clinical trial
Dec 1, 1994First marketed drug
Dec 28, 1989First NDA
Dec 29, 1993Last known activity
Sep 11, 2025
Timeline
1900s
- Jul 1, 1908
Leo Pharma— Founded
2000s
- Dec 8, 2000
tacrolimus— NDA Secondary Org
- Nov 1, 2009
Peplin— Acquired
2010s
- Nov 17, 2015
Astellas— Acquired
2020s
- Dec 27, 2021
tralokinumab— Marketing Organization
- Aug 4, 2023
avacincaptad pegol— NDA Organization
- Aug 21, 2023
Timber Pharmaceuticals LLC— Acquired
Drugs by trial phase (462 distinct, 1425 trials)
Phase 4 (14 own, 83 via acquisition)
Phase 3 (9 own, 97 via acquisition)
Phase 2 (16 own, 113 via acquisition)
Phase 1 (14 own, 102 via acquisition)
Indications
Approved for
Studied for
- Acne Vulgaris
- Acute Chest Syndrome
- Acute Lung Injury
- Alopecia
- Alopecia Areata
- Atrophy
- Basal Cell Carcinoma
- Birth Weight
- Body Weight
- Carcinoma
- Carcinoma, Hepatocellular
- Carcinoma, Squamous Cell
- Condylomata Acuminata
- Connective Tissue Diseases
- Dermatitis
- Dermatitis, Atopic
- Dermatitis, Contact
- Dermatitis, Occupational
- Dermatitis, Phototoxic
- Disseminated Intravascular Coagulation
- Eczema
- Embolism
- Fetal Growth Retardation
- Hyperparathyroidism
- Hyperparathyroidism, Secondary
- Impetigo
- Inflammation
- Insulin Resistance
- Keratosis
- Keratosis, Actinic
- Kidney Failure, Chronic
- Liver Neoplasms
- Lung Injury
- Lupus Erythematosus, Discoid
- Lupus Erythematosus, Systemic
- Lymphoma
- Mastocytosis
- Molluscum Contagiosum
- Multiple Myeloma
- Neoplasm Metastasis
- Neoplasms, Plasma Cell
- Prurigo
- Pruritus
- Psoriasis
- Pulmonary Embolism
- Renal Insufficiency
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Sepsis
- Syndrome
- Thromboembolism
- Thrombosis
- Venous Thromboembolism
- Venous Thrombosis
- Warts
Marketed drugs (18)
Subsidiaries (3 direct, 24 total across the full acquisition tree)
- Astellas
- Peplin
- Timber Pharmaceuticals LLC
- Agensys, Inc. L2
- Audentes Therapeutics L2
- BioPharmX L2
- Dynogen Pharmaceuticals L2
- Fujisawa L2
- Ganymed Pharmaceuticals AG L2
- Iveric Bio L2
- Mitobridge L2
- Neosil, Inc. L2
- Ocata Therapeutics L2
- Ogeda S.A. L2
- OSI Pharmaceuticals L2
- Perseid Therapeutics LLC L2
- Potenza Therapeutics L2
- Propella Therapeutics L2
- Quethera L2
- Universal Cells Inc. L2
- Yamanouchi Pharmaceuticals L2
- Cell Pathways, Inc. L3
- Lyphomed, Inc. L3
- Mytogen, Inc. L3
Recent trials (50)
- NCT07013201Lead sponsorPhase 2Sep 11, 2025
- NCT07013201OfficialPhase 2Sep 11, 2025
- NCT06444867Lead sponsorPhase 1Nov 30, 2024
- NCT06444867OfficialPhase 1Nov 30, 2024
- NCT06311682Lead sponsorPhase 3Jun 10, 2024
- NCT06311682OfficialPhase 3Jun 10, 2024
- NCT05923099Study directorPhase 2Sep 20, 2023
- NCT05923099Lead sponsorPhase 2Sep 20, 2023
- NCT06773455CollaboratorPhase 4Sep 11, 2023
- NCT06004050Study directorPhase 3Sep 5, 2023
- NCT06004050Lead sponsorPhase 3Sep 5, 2023
- NCT05958407Lead sponsorPhase 3Aug 28, 2023
- NCT05958407Study directorPhase 3Aug 28, 2023
- NCT05919082Lead sponsorPhase 3Jun 21, 2023
- NCT05919082Study directorPhase 3Jun 21, 2023
Details
- Founded
- Copenhagen, DK Jul 1, 1908
- First NDA
- Dec 29, 1993
- Last known activity
- Sep 11, 2025
Designations held
- Orphan drug
- Fast track
- Priority review
- Breakthrough therapy