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Drug information

Drug's link(s)

Not provided

Generic name

ACC017 (investigational)

Brand names

Not applicable (investigational; no brand name assigned)

Compound type

Small molecule

Drug class/category

INSTI (Integrase strand transfer inhibitor)

Summary

ACC017 is an investigational integrase strand transfer inhibitor (molecular formula C22H21F2N3O5; CAS 2765212-92-6) discovered and developed by Jiangsu Aidea Pharmaceutical Group (China), with preclinical work at the Kunming Institute of Zoology, Chinese Academy of Sciences. In vitro, it showed potent activity against HIV-1 IIIB (EC50 0.59 nM), clinical isolates (EC50 0.11-1.78 nM) and a panel of drug-resistant strains (EC50 0.34-9.12 nM); resistance selection yielded D232N and R263K without G140 or Q148 pathway mutations. ACC017 is developed as a once-daily oral tablet: a placebo-controlled phase 1b/2a monotherapy study (NCT06719310) showed potent antiviral activity and PK supporting once-daily dosing. A phase 3 trial versus dolutegravir in treatment-naive adults (about 660 participants, 48 weeks) started in China in October 2025. No long-acting formulation has been reported.

Approval status

ACC017 is an investigational INSTI being developed as a once-daily oral tablet, now in phase 3. A three-drug fixed-dose combination (ADC118: ACC017/FTC/TAF) received NMPA clinical trial approval on 28 October 2025.

Regulatory authorities

Not officially reported

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Oral

Associated long-acting platforms

Oral solid form

Use of drug

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

Dosage

Available dose and strength

Oral tablets; 5 mg, 40 mg and 80 mg once daily studied in phase 1b/2a (NCT06719310). Phase 3 dose not disclosed.

Maximum dose

80 mg once daily (highest dose in phase 1b/2a)

Recommended dosing regimen

Not established. Phase 1b/2a (NCT06719310): ACC017 5, 40 or 80 mg once daily monotherapy for 10 days, then with FTC/TAF 200/25 mg once daily for 18 days. Phase 3 (CTR20253999): ACC017-based regimen versus dolutegravir, 48 weeks (dose not disclosed).

Additional comments

Not provided

Dosage link(s)

Not provided

Related entries

Not provided

Additional information

Not provided

Developer(s)

Aidea Pharma
Originator
China

Aidea Pharma

Jiangsu Aidea Pharmaceutical is a Shanghai-listed Chinese pharmaceutical company based in Yangzhou, Jiangsu, whose pipeline includes several anti-HIV medicines.

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 & 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)

Not provided

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL