Drug & Device Pipeline News

July 25, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Escend Pharmaceuticals	ES-3000	Relapsed or refractory acute myeloid leukemia	IND approved by the FDA
Sorrento Therapeutics	STI-1558	COVID-19	IND approved by the FDA
Omega Therapeutics	OTX-2002	Hepatocellular carcinoma	IND approved by the FDA for a phase 1/2 trial
Therapeutic Solutions International	JadiCell Universal Donor Stem Cell	COVID-19 acute respiratory distress syndrome	Emergency IND approved by the FDA
Lantern Pharmaceuticals	LP-300 in combination with chemotherapy	Advanced non-small cell lung cancer in patients who have never smoked	Approval for a phase 2 trial granted by the FDA
Trials Initiated
HutchMed	HMPL-A83	Advanced malignant neoplasms	Initiation of phase 1 trial in China
Eledon Pharmaceuticals	Tegoprubart	Patients undergoing kidney transplantation	Initiation of phase 1b trial
Immunomic Therapeutics	ITI-3000	Merkel cell carcinoma	Initiation of phase 1 trial
LG Chem	LG203003	Non-alcoholic steatohepatitis	Initiation of phase 1 trial
Siolta Therapeutics	STMC-103H	Atopic diseases in neonates and infants at risk for developing allergic disease	Initiation of phase 1b/2 trial
ADC Therapeutics	Zynlonta in combination with rituximab	First-line diffuse large B-cell lymphoma	Initiation of phase 2 trial
Cardior Pharmaceuticals	CDR132L	Heart failure after myocardial infarction	Initiation of phase 2 trial
Cardurion Pharmaceuticals	CRD-740	Heart failure	Initiation of phase 2 trial
Daiichi Sankyo	DS-7300	Pretreated extensive-stage small cell lung cancer	Initiation of phase 2 trial
George Medicines	GMRx4	Type 2 diabetes	Initiation of phase 2 trial
MAIA Biotechnology	THIO	Non-small cell lung cancer	Initiation of phase 2 trial
Yuyu Pharmaceuticals	YP-P10	Dry eye disease	Initiation of phase 2 trial
CANbridge Pharmaceuticals	CAN108 (maralixibat)	Biliary atresia	Initiation of phase 2 trial in China
Impel Pharmaceuticals	INP105 (nasal olanzapine)	Acute agitation in adolescents with autism spectrum disorder	Initiation of phase 2a trial
Aytu BioPharma	Enzastaurin	COL3A1-positive vascular Ehlers-Danlos syndrome	Initiation of phase 3 trial
Capricor Therapeutics	CAP-1002	Late-stage Duchenne muscular dystrophy	Initiation of phase 3 trial
Sinovac Biotech	Quadrivalent influenza vaccine	Influenza	Initiation of phase 3 trial in Chile
Approvals
Azurity Pharmaceuticals	Zonisade (zonisamide oral suspension)	Partial seizures in patients 16 and older with epilepsy	Approved by the FDA
Incyte	Opzelura (ruxolitinib) cream	Nonsegmental vitiligo in patients 12 and older	Approved by the FDA
Vivus	Qsymia (phentermine and topiramate extended-release capsules) CIV	Obesity in adolescents 12 to 17 years old	Approved by the FDA for expanded age indication
Calliditas Therapeutics	Kinpeygo	Primary immunoglobulin A (IgA) nephropathy in adults at risk of rapid disease progression	Approved by the European Commission
Simcere Pharmaceuticals	Cosela (trilaciclib hydrochloride for injection)	Chemotherapy-induced myelosuppression in adults	Approved in China