With three new molecular entity
approvals in July, the total number of NME approvals this year rose to 15, which pales before the 25 approvals that came through the same time last year.
Additionally, Chidamide is a new molecular entity
with global patent protection developed by Chipscreen Biosciences, China's first international-recognised subtype selective histone deacetylation enzyme (HDAC) oral inhibitor and a national class 1.1 drug.
Brexanolone is an allosteric modulator of GABAA receptors and "a new molecular entity
not currently marketed anywhere in the world for any indication," according to the FDA document.
Chicago: Fitch Ratings said new molecular entity
(NME) approvals are down 44% year over year.
NKTR-181 is a new molecular entity
and the first analgesic opioid molecule to exhibit a reduced incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics.
These projects include the clinical development of three products in Phase 3 and a new molecular entity
in Phase 1, preparations for the upcoming release of two products for psoriasis in Europe, one is a biological product and to continue to support the new launchings during 2016 in the United States as well as growth in the aesthetic area.
Despite the odds of a new molecular entity
becoming an approved drug being extremely long, the dominant IP is vested in chemical composition of matter.
Andrey Leonov, Chief Executive Officer of Incuron, LLC, commented, "We are excited to start clinical trials with CBLC137, a proprietary new molecular entity
. This initial trial is expected to generate valuable input on the future development of CBLC137.
They, along with efficacy, are critical properties in determining whether a new molecular entity
will become a clinical candidate and subsequently, another drug on the market.
Considered a new molecular entity
by the FDA, naproxcinod, which is taken orally, is enzymatically cleaved in vivo to release two active metabolites-naproxen and nitric oxide.
Omacetaxine, a new molecular entity
and first in a class of cephalotaxines, is a synthetic formulation of homoharringtonine, a drug isolated from the evergreen tree Cephalotaxus in China.
"We also considered the patient populations in need of additional treatment options, existing treatments and whether this was a new molecular entity