access-principles-1access-principles-2access-principles-3backcarrierdevelopmentease_of_administrationexportimplantableinjectablenon-implantablenon_carriernon_injectableother_featuresprintroute_of_administrationtherapeutic_areatype_of_tech

Drug information

Drug's link(s)

Not provided

Generic name

MK-8527

Brand names

Not provided

Compound type

Small molecule

Summary

MK-8527 is a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently in clinical development for the prevention and treatment of HIV-1. MK-8527 functions by preventing the translocation of the HIV reverse transcriptase enzyme, thereby disrupting viral replication. A Phase II study assessing MK-8257 as once-monthly oral PrEP in participants at low-risk for HIV-1 infection is currently in progress (NCT06045507).

Approval status

Unknown

Regulatory authorities

Unknown

Therapeutic area(s)

  • HIV
Use case(s)
  • Pre-Exposure Prophylaxis (PrEP)
  • Treatment

Administration route

Oral

Associated long-acting platforms

Oral solid form

Use of drug

Ease of administration
  • Self-administered
User acceptance

Not provided

Associated technologies

Not provided

Comment & Information

Not provided

Developer(s)

Merck
Originator
United States

Merck & Co., Inc. is an American multinational pharmaceutical company known as Merck Sharp & Drone (MSD) in territories outside of the USA and Canada. Merck was originally established in 1891, and is currently headquartered in Rahway, New Jersey. The company is particularly well known for developing and manufacturing biologic therapies, vaccines, medicines and animal health products.

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Excipients

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Delivery device(s)

No delivery device

Description

4'-SUBSTITUTED NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Brief description

4'-substituted nucleoside derivatives of Formula I and their use in the inhibition of HIV reverse transcriptase, the prophylaxis of infection by HIV, the treatment of infection by HIV, and the prophylaxis, treatment, and delay in the onset or progression of AIDS and/or ARC.

Representative patent

WO2015143712

Category

Compound

Patent holder

Merck Sharp & Dohme Corp.

Exclusivity

Not provided

Expiration date

March 28, 2034

Status

Granted in 36 countries: AL, AM, AP (BW, GH, KE, NA), AT, AU, AZ, BA, BE, BG, BY, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DZ, EA, EE, ES, FI, FR, GB, GC, GE, GI, GR, GY, HN, HR, HU, ID, IE, IL, IR, IS, IT, JO, JP, KR, KZ, LB, LT, LU, LV, MA, ME, MK, MN, MT, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RS, RU, SC, SE, SG, SI, SK, TN, TR, TT, TW, UA, US, VE, VN, ZA Filed in 13 countries: AR, BB, BN, BR, BZ, DO, EC, EG, GT, IN, JM, LK, NI, SV, TH As of 27 June 2024 - MPP Search

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

There are no additional links

Collaborate for development

Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology

Share technical information for match-making assessment

Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit

Work with MPP to expand access in LMICs

In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing