Leadiant Biosciences
U.S.-based, research-focused pharmaceutical company dedicated to the discovery, development, and distribution of therapies for rare diseases. Activities include rare-disease R&D, clinical development, product lifecycle management, manufacturing oversight, specialty-distribution, patient engagement, and regulatory/compliance programs. Headquartered in Rockville, Maryland.
Industries
Nr. of Employees
large (251-1000)
Patents
Products
Carnitine (levocarnitine) - oral and injectable formulations
Marketed levocarnitine formulations provided as tablets, oral solutions (including sugar-free) and injectable preparations for primary and secondary carnitine deficiency and certain dialysis-related indications.
Topical ophthalmic cysteamine solution (ophthalmic formulation)
Ophthalmic cysteamine topical solution indicated for treatment of corneal cystine crystal accumulation in patients with cystinosis; distributed via specialty pharmacy channels.
Procarbazine hydrochloride capsules (oral chemotherapy)
Oral procarbazine hydrochloride capsules indicated for treatment of Hodgkin lymphoma, with prescribing information and boxed warning documentation available.
Carnitine (levocarnitine) - oral and injectable formulations
Marketed levocarnitine formulations provided as tablets, oral solutions (including sugar-free) and injectable preparations for primary and secondary carnitine deficiency and certain dialysis-related indications.
Topical ophthalmic cysteamine solution (ophthalmic formulation)
Ophthalmic cysteamine topical solution indicated for treatment of corneal cystine crystal accumulation in patients with cystinosis; distributed via specialty pharmacy channels.
Procarbazine hydrochloride capsules (oral chemotherapy)
Oral procarbazine hydrochloride capsules indicated for treatment of Hodgkin lymphoma, with prescribing information and boxed warning documentation available.
Services
Provision of product and safety information to healthcare professionals via phone, fax and email; dedicated contact lines for medical inquiries.
Programs and phone support for patient assistance, reimbursement guidance, and access to prescription therapies.
Policies and contact routes for expanded access requests and investigator-initiated trial concept submissions for investigational therapies.
Provision of product and safety information to healthcare professionals via phone, fax and email; dedicated contact lines for medical inquiries.
Programs and phone support for patient assistance, reimbursement guidance, and access to prescription therapies.
Policies and contact routes for expanded access requests and investigator-initiated trial concept submissions for investigational therapies.
Expertise Areas
- Rare disease therapeutics
- Clinical trial management
- Regulatory compliance and pharmacovigilance
- Drug formulation and dosage form development
Key Technologies
- Clinical trial management systems
- Drug formulation for oral, injectable, and ophthalmic products
- Regulatory submission and labeling processes
- Pharmacovigilance and adverse event reporting systems
News & Updates
Announcement of Canadian regulatory approval for a topical ophthalmic cysteamine solution indicated for corneal cystine crystal accumulation in cystinosis.
Announcement of a license agreement and cooperative research and development agreement (CRADA) with the NIH to develop an oral therapeutic for GNE myopathy.
Announcement of corporate name change and recommitment to development and commercialization of medicines for rare diseases.
Announcement of Canadian regulatory approval for a topical ophthalmic cysteamine solution indicated for corneal cystine crystal accumulation in cystinosis.
Announcement of a license agreement and cooperative research and development agreement (CRADA) with the NIH to develop an oral therapeutic for GNE myopathy.
Announcement of corporate name change and recommitment to development and commercialization of medicines for rare diseases.