This section highlights FDA-related milestones and regulatory updates for drugs developed by Akari Therapeutics (AKTX).
Over the past two years, Akari Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AR-V7 and PAS-nomacopan. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AR-V7 FDA Regulatory Events
AR-V7 is a drug developed by Akari Therapeutics for the following indication: for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AR-V7
- Announced Date:
- September 24, 2025
- Indication:
- for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer.
Announcement
Akari Therapeutics announced key preclinical data demonstrating the potential of its novel antibody drug conjugate (ADC) spliceosome modulating payload, PH1, for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer.
AI Summary
Akari Therapeutics announced preclinical data showing its new antibody drug conjugate (ADC) payload, called PH1, can lower the levels of the AR-V7 receptor that drives metastatic castration-resistant prostate cancer. AR-V7–driven tumors do not respond to current androgen receptor inhibitors like Xtandi or Erleada, creating a pressing need for targeted treatments.
In lab tests with a hormone-refractory cell model (22Rv1), PH1 dramatically reduced AR-V7 expression, while standard AR pathway inhibitors had no effect. In a different, hormone-sensitive prostate cancer model (LnCAP), PH1 alone slowed tumor cell growth and showed added benefit when combined with Xtandi or Erleada.
Akari believes that pairing PH1-conjugated ADCs with AR inhibitors could delay or prevent resistance by lowering AR-V7 and slowing cancer progression. The company plans further studies to test this approach against different prostate cancer targets and explore first-line combination regimens.
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PAS-nomacopan FDA Regulatory Events
PAS-nomacopan is a drug developed by Akari Therapeutics for the following indication: Treatment for geographic atrophy (GA).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PAS-nomacopan
- Announced Date:
- August 19, 2024
- Indication:
- Treatment for geographic atrophy (GA).
Announcement
Akari Therapeutics that the company has received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, which provides additional clarity on Akari's final Investigational New Drug Application (IND)- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy (GA).
AI Summary
Akari Therapeutics announced that it received positive and constructive Pre-IND feedback from the FDA on July 29, 2024. This feedback provides additional clarity on the company’s final Investigational New Drug (IND) application by outlining key aspects of its preclinical studies, drug manufacturing, and Phase 1 clinical strategy for its long-acting PAS-nomacopan. The drug is designed for intravitreal treatment of geographic atrophy (GA) and may offer benefits such as longer intervals between injections and a potential decrease in the risk of choroidal neovascularization.
With this regulatory guidance, Akari’s path forward to filing an IND application in 2025 is clearer. The company is preparing to utilize a full-scale batch of GMP-manufactured drug substance for the final IND-enabling studies, setting the stage for its first clinical studies aimed at offering improved therapy options for patients with GA.
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