News Detail

Global drug developments

Jul 3, 2020

Global drug developments

Drug name: umbralisib

CAS: 1532533-67-7

Target and IC50: PI3Kδ, 22.2 nM

Indications: chronic lymphocytic leukemia

Development company: TG

Development status: On May 5, 2020, TG Therapeutics announced that the UNITY-CLL Phase III clinical study (evaluating Umbralisib and Ublituximab (U2) for the combined treatment of chronic lymphocytic leukemia) reached a positive top-line result.

Drug Name: Vadadustat

CAS: 1000025-07-9

Target and IC50: hypoxia-inducible factor prolyl hydroxylase (HIF-PH)

Indications: Anemia

Development company: Akebia

Development status: May 5, 2020 Akebia Therapeutics announced that Vadadustat's global phase 3 treatment of anemia caused by dialysis in adult kidney disease has achieved top results.

Drug Name: secnidazole

CAS: 3366-95-8

Target and IC50:

Indication: Trichomoniasis

Development company: Lupin

Development status: On May 4, 2020, Lupin announced that its single-dose Solosec® (secnidazole) has achieved positive top-line results in a phase III clinical study for the treatment of trichomoniasis. It is planned to submit a supplemental application for a new drug of Solosec® for trichomoniasis to the FDA in the second half of 2020.

Drug Name: Sarizotan

CAS: 177975-08-5

Target and IC50: HTR1A, DRD2

Indication: Neurodevelopmental disease Rett syndrome

Development company: Newron

Development status: On May 4, 2020, Newron Corporation announced that Sarizotan’s STARS clinical study for the treatment of neurodevelopmental disease Rett syndrome has evaluated the efficacy, and it has not shown evidence of efficacy for the primary or secondary efficacy variables.

Rett syndrome is a serious neurodevelopmental disorder that mainly affects women, with an estimated prevalence of one in 10,000. There is currently no approved treatment. It is characterized by the loss of fine and rough motor skills acquired, and the development of neurological, cognitive, and autonomic dysfunction, which leads to the loss of people's ability to perform daily activities, walk, or communicate. Rett syndrome is also associated with reduced life expectancy. About 25% of deaths in patients with Rett syndrome may be related to multiple cardiac respiratory rhythm insufficiency caused by immature brain stem and autonomic failure. Over 95% of the MeCP2 genes in these patients have random mutations. At some point, approximately 70% of patients with Rett syndrome found apnea, hyperventilation, and abnormal breathing.

Drug name: QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate)


Indication: Adult asthma

Development company: Novartis

Development status: On May 1, 2020, the European Medicines Agency (EMA) Committee for Human Pharmaceutical Products (CHMP) has issued a positive review opinion, recommending approval of Enerzair Breezhaler (QVM149; indacaterol acetate/glycopyrronium bromide/mometasone furoate, indene acetate Datrol/ glycopyrronium bromide/ mometasone furoate; IND/GLY/MF) as a maintenance therapy for long-acting β2 receptor agonists (LABA) and high-dose inhaled corticosteroids (ICS) Adult patients with asthma who have failed to fully control the condition of the combination regimen and have experienced one or more asthma exacerbations in the previous year.

Drug Name: Encorafenib

CAS: 1269440-17-6

Target and IC50: 0.3 nM (BRafV600E)

Indication: BRAFV600E-mutant metastatic colorectal cancer

Development company: Pierre Fabre

Development status: On May 1, 2020, the European Medicines Agency (EMA) Committee for Medical Products for Human Use (CHMP) has issued a positive review opinion, recommending approval of the combination of Braftovi (encorafenib) and Erbitux (cetuximab, cetuximab) Medication regimen (Braftovi two-drug regimen) is used to treat adult patients with metastatic colorectal cancer (mCRC) who have previously received systemic therapy but whose disease has progressed (treatment) and carry the BRAF V600E mutation.

Drug Name: CC-486 (oral azacitidine)

CAS: 320-67-2

Target and IC50: DNMT1, Nucleoside Antimetabolite/Analog, Autophagy

Indications: acute myeloid leukemia

Development company: Bristol-Myers Squibb (BMS)

Development status: On May 1, 2020, the US Food and Drug Administration (FDA) has accepted a new drug application for CC-486 (oral azacitidine), which is an oral hypomethylation agent used to maintain treatment intensification Adult patients with acute myeloid leukemia (AML) whose condition is in remission after induction chemotherapy, specifically: used to achieve first complete remission (CR) or complete recovery of blood cell count after intensive induction chemotherapy (with or without consolidation chemotherapy) Remission (CRi), maintenance treatment for adult patients with AML who are unsuitable or choose not to undergo hematopoietic stem cell transplantation (HSCT). The FDA has granted the NDA priority review and has designated a target date for the Prescription Drug User Fee Act (PUDFA) of September 3, 2020.