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
AKTX-101, 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.
AKTX-101 FDA Regulatory Timeline and Events
AKTX-101 is a drug developed by Akari Therapeutics for the following indication: in pancreatic cancer driven by K-Ras mutations.
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:
- AKTX-101
- Announced Date:
- April 20, 2026
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics, Plc announced the presentation of positive preclinical data for its lead TROP2-targeting ADC, AKTX-101, at the American Association for Cancer Research (AACR) Annual Meeting 2026.
AI Summary
Akari Therapeutics announced positive preclinical results for AKTX-101, its lead TROP2-targeting antibody-drug conjugate (ADC), presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. AKTX-101 uses a novel RNA spliceosome-targeting payload called PH1, differing from current TROP2 ADCs that carry Topoisomerase I inhibitor payloads.
In head-to-head lab models, AKTX-101 showed greater potency and/or higher maximum cancer cell killing than Topoisomerase I inhibitor TROP2 ADCs across bladder, lung and breast tumor models. It achieved sub-nanomolar potency in all bladder cancer lines tested and in several non-small cell lung cancer lines driven by EGFR, BRAF and SMARCA4. It also killed HER2 breast cancer cells that are resistant to existing Topoisomerase I inhibitor ADCs like trastuzumab deruxtecan.
Because PH1 targets RNA splicing and may activate immune responses, Akari says AKTX-101 could overcome resistance seen with Topoisomerase I ADCs. The data support advancing AKTX-101 into Phase 1 studies and suggest potential to expand the TROP2 ADC class across multiple solid tumors.Read Announcement
- Drug:
- AKTX-101
- Announced Date:
- December 23, 2025
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics announced the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company's lead ADC program.
AI Summary
Akari Therapeutics announced it has started GMP manufacturing activities to support development of its lead antibody-drug conjugate, AKTX-101. The company selected WuXi XDC, a global leader in ADC development and manufacturing, to perform the IND-enabling work and produce GMP-grade drug material. Akari said the partnership is meant to accelerate and ensure high-quality production ahead of clinical testing.
AKTX-101 carries Akari’s novel PH1 payload, a spliceosome modulator that disrupts RNA splicing in cancer cells and aims to combine direct tumor killing with immune activation. Preclinical results suggest strong activity and possible synergy with checkpoint inhibitors. The GMP work is intended to support a planned Phase 1 first-in-human study in about 12 months (targeting late 2026 or early 2027), subject to regulatory clearance. Akari and WuXi XDC described the effort as a key step toward taking AKTX-101 into the clinic.
Read Announcement- Drug:
- AKTX-101
- Announced Date:
- December 9, 2025
- Indication:
- in pancreatic cancer driven by K-Ras mutations
Announcement
Akari Therapeutics, Plc announced key preclinical data demonstrating the therapeutic potential of its novel ADC targeting Trop2, AKTX-101, in pancreatic cancer driven by K-Ras mutations, one of the deadliest and most treatment-resistant forms of cancer.
AI Summary
Akari Therapeutics reported preclinical data showing its Trop2-targeting antibody-drug conjugate AKTX-101 killed pancreatic cancer cell lines driven by the K-Ras G12V mutation. AKTX-101 showed single-digit nanomolar cytotoxic potency across tested K‑Ras G12V PDAC lines and outperformed daraxonrasib in multiple cell models. The K‑Ras G12V mutation drives about one third of pancreatic ductal adenocarcinoma (PDAC), a lethal disease with median overall survival around 1.4 years and very few effective targeted therapies.
AKTX-101 delivers a novel PH1 spliceosome‑modulating payload into Trop2‑positive tumor cells; Trop2 is often highly expressed in PDAC and higher in K‑Ras mutated tumors. PH1 disrupts RNA splicing to kill cancer cells and may stimulate immune responses. Akari plans to advance AKTX-101 toward a first‑in‑human trial in late 2026 and is exploring partnerships to develop PH1 for other ADCs. These results support further development in this hard-to-treat cancer.
Read Announcement
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.
Read Announcement
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.
Read Announcement
