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Drug information

Drug's link(s)
Generic name

MK-8507

Brand names

Not provided

Compound type

Small molecule

Drug class/category

NNRTI

Summary

MK-8507, also known as Ulonivirine, is a selective, potent and novel non-nucleoside reverse transcriptase inhibitor (NNRTI) currently in clinical development for the treatment of HIV-1. MK-8507 inhibits HIV-1 allosterically through the classic NNTRI binding location adjacent to the polymerase active site. Preclinical research indicates that MK-8507 displays activity against the most common resistance mutations associated with NNRTIs (e.g. Y181C and K103N) and possesses strong antiviral effects. The pharmacokinetics of MK-8507 support once-weekly oral administration.

Approval status

Ulonivirine (previously known as MK 8507) is an orally-administered investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by MSD for the treatment of HIV-1 infection. It is not approved yet.

Regulatory authorities

Ulonivirine is not approved yet.

Therapeutic area(s)

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

Administration route

Oral

Associated long-acting platforms

Oral solid form

Use of drug

Ease of administration
  • Self-administered
Frequency of administration
  • Weekly
User acceptance
Not provided

Dosage

Available dose and strength

Not provided

Maximum dose

Not provided

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Main compound
Compare
Ulonivirine (MK-8507)
Related compounds

Islatravir (ISL)

Associated formulations and regimens
Compare

MK-8591B (islatravir + ulonivirine)

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

Merck / MSD
Originator
United States

Merck / MSD

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

Unknown

Tentative equipment list for manufacturing

Unknown

Manufacturing

Unknown

Specific analytical instrument required for characterization of formulation

Unknown

Excipients & delivery device(s)

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

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided