Drugs / NFL-101
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02521701 | Dec 2014 → Dec 2015 | — | Institut du Cancer de Montpellier - Val d'Aurelle | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT06091826 | Feb → Sep 2023 | nicotine dependence | NFL Biosciences SAS | Completed | No outcome recorded |
| Phase 2 | NCT04571216 | Apr 2021 → Apr 2024 | nicotine dependence | NFL Biosciences SAS | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | NFL Biosciences SAS | Results NFL Biosciences releases new results on NFL-101 and reaffirms its personalized approach to smoking cessation nflbiosciences.com ↗
The most reliable comparison is the one measured 3 months after the end of treatment: over this period, NFL -101 efficacy in the target population reached 27.9%, approximately 30% higher than Champix efficacy (21.8%) in EAGLES. |
| 2025-12-08 | NFL Biosciences SAS | Results NFL Biosciences obtains complementary characterization results for NFL-101, its first-in-class drug candidate for smoking cessation, and prepares a new patent application nflbiosciences.com ↗ |
| 2025-09-01 | NFL Biosciences SAS | Results NFL Biosciences announces the publication of the results of its Phase II clinical trial CESTO II evaluating NFL-101 in smoking cessation in Nicotine & Tobacco Research, the official journal of the Society for Research on Nicotine and Tobacco (SRNT) nflbiosciences.com ↗
Two administrations of NFL -101 at the 100 µg dose demonstrated a significant increase in continuous abstinence and a durable reduction in craving, the irresistible urge to smoke |
| 2025-05-05 | NFL Biosciences SAS | Results NFL Biosciences announces results from a new study conducted with the CEA providing further insight into the effects of NFL-101, its first-in-class treatment for tobacco addiction, and highlighting its prolonged activity nflbiosciences.com ↗
These results enable a more precise identification of the brain regions targeted by NFL -101. |
| 2025-03-24 | NFL Biosciences SAS | Results NFL BIOSCIENCES presents the immunological analysis results of its phase 2 CESTO II study confirming the efficacy of NFL-101, its first-in-class treatment for tobacco addiction nflbiosciences.com ↗ |
| 2025-02-04 | NFL Biosciences SAS | Results NFL BIOSCIENCES publishes positive results from a complementary program confirming the excellent safety profile of NFL-101, its first-in-class treatment for tobacco addiction nflbiosciences.com ↗ |
| 2024-07-15 | NFL Biosciences SAS | Results CESTO II study results nflbiosciences.com ↗
NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of addictions, is announcing the results of its phase 2 clinical trial CESTO II for NFL-101, its smoking cessation drug candidate. |
| 2024-01-30 | NFL Biosciences SAS | Results Success of the study with the CEA nflbiosciences.com ↗
The three stages of the study with the CEA have been validated and show the central effects of the treatment with NFL-101. |
| 2023-06-21 | NFL Biosciences SAS | Regulatory Approval for its patent to be granted on NFL-101 in Europe and approval of the clinical development nflbiosciences.com ↗
Alongside this, the European Medicines Agency (EMA), following the request for scientific advice submitted by NFL Biosciences, approved the clinical development plan for NFL-101. |
| 2022-11-08 | NFL Biosciences SAS | Regulatory Clinical trial approved to demonstrate the complementarity of NFL-101 with other smoking cessation treatments nflbiosciences.com ↗
NFL BIOSCIENCES: CLINICAL TRIAL APPROVED TO DEMONSTRATE THE COMPLEMENTARITY OF NFL-101 WITH OTHER SMOKING CESSATION TREATMENTS |
| 2022-04-11 | NFL Biosciences SAS | Regulatory Decision to approve the issuing of its patent in China nflbiosciences.com ↗
This patent will protect the innovation that NFL-101 is based on through to 2036 in China. |
| 2021-09-15 | NFL Biosciences SAS | Regulatory Phase II/III clinical trial for NFL-101 for smokingcessation approved in France nflbiosciences.com ↗ |
| 2021-06-02 | NFL Biosciences SAS | Regulatory French smoking cessation innovation approved for Phase II/III clinical trial (french only) nflbiosciences.com ↗
Un essai clinique de Phase II approuvé par le Comité d'éthique de la recherche sur l'homme (HREC) en Australie pour s’affranchir des effets de la crise sanitaire en Europe |
All press releases naming this drug 22 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NFL 101 | “This new drug (NFL 101) was assessed in preclinical studies.” NCT02521701 ↗ |
| Modality | Protein / enzyme biologic | “NFL-101) consisting of a nicotine-free extract of tobacco proteins” NCT04571216 ↗ |
| Route | Subcutaneous | “Subcutaneous injections” NCT04571216 ↗ |