Paraplatin

(Carboplatin Injection)

AAvyxa

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Solid Tumour

NCT06783647

Q4 2027

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT06514027

Q3 2028

Phase 3Recruiting

NSCLC (advanced Non-Small Cell Lung Cancer)

NCT06956001

Phase 1Active, not recruiting

Small Cell Lung Carcinoma

NCT07009457

Q2 2029

Phase 3Recruiting

Relapsed/refractory Diffuse Large B-Cell Lymphoma

NCT06792253

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

A Randomized, Controlled, Open-label, Multicenter Phase III Study of SHR-A1811 Combined With Adebrelimab for the First-line Treatment of Patients With HER2-overexpressing Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

Not yet recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 3·NCT07896005·436 enrolled

A Multicenter, Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations

Recruiting·BBeBetter Med Inc·Phase 2·NCT06514027·30 enrolled

Endometrial Carcinoma1 trial

A Randomized, Double-Blind, Multicenter Phase III Clinical Trial of HB0025 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-Line Treatment for Advanced or Recurrent Endometrial Cancer

Recruiting·SShanghai Huaota Biopharmaceutical Co., Ltd.·Phase 3·NCT07902999·333 enrolled

Extra-pulmonary Neuroendocrine Carcinoma1 trial

A Randomized, Double-blind, Placebo-controlled, Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment of Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)

Not yet recruiting·NNanjing Leads Biolabs Co.,Ltd·Phase 3·NCT07720193·280 enrolled

Solid Tumour1 trial

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 01(NSCLC)]

Recruiting·NNanjing Leads Biolabs Co.,Ltd·Phase 2·NCT06783647·250 enrolled

Relapsed/Refractory Diffuse Large B-cell Lymphoma1 trial

Phase Ⅲ Clinical Trial Comparing BEBT-908 Combined With Rituximab (R) to Standard of Care for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Recruiting·BBeBetter Med Inc·Phase 3·NCT06792253·416 enrolled

5 more indications

Triple-Negative Breast Cancer1 trial

A Phase II Study of BEBT-209 in Combination With Carboplatin and Gemcitabine for the Treatment of Advanced Triple-Negative Breast Cancer

Completed·BBeBetter Med Inc·Phase 2·NCT06685796·65 enrolled

Locally Advanced Triple-negative Breast Cancer1 trial

A Randomized, Controlled, Open-label, Multi-center, Phase IIb/III Clinical Study to Evaluate BEBT-209 Plus Carboplatin and Gemcitabine Versus Carboplatin Plus Gemcitabine in Locally Advanced or Metastatic Triple-Negative Breast Cancer

Recruiting·BBeBetter Med Inc·Preclinical·NCT07544056·446 enrolled

NSCLC Patients With Brain Metastasis1 trial

A Phase III, International, Multicenter, Randomized, Controlled, Open-label Clinical Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases

Recruiting·AAllist Pharmaceuticals, Inc.·Phase 3·NCT06970639·380 enrolled

NSCLC (Advanced Non-small Cell Lung Cancer)1 trial

A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation

Recruiting·AAllist Pharmaceuticals, Inc.·Phase 3·NCT06956001·300 enrolled

Small Cell Lung Carcinoma1 trial

An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer

Active, not recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 1·NCT07009457·24 enrolled

Regulatory

FDA Approval Timeline[3]

Mar 3, 1989

PARAPLATIN

NDA NDA019880

Jul 14, 2003

PARAPLATIN

NDA NDA020452

Aug 8, 2025

KYXATA

NDA NDA219921

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Carboplatin Injection. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Carboplatin Injection compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA219921). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Avyxa company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Company: AAvyxa