§02 · What We Do

Research incentral-nervous stimulants,manufactured as API intermediates.

We operate at three tightly coupled altitudes: discovery of novel CNS-active scaffolds, preclinical characterisation of lead candidates, and process-scale manufacturing of the intermediate compounds our partners require.

Every internal program targets a stimulant, eugeroic or cognition-enhancing profile with explicit deprioritisation of high abuse-liability chemotypes. Our screening cascade emphasises atypical DAT engagement, selectivity indices and cardiovascular safety.

On the commercial side, we ship GMP-aligned API intermediates against Drug Master Files, with full CoA, ICH-Q3A/D residuals, and process capability data (Cp/Cpk) for every batch.

Pipeline

6 active programs

Compound

Class

Stage

Indication

Partner

DMF

NGP-107

Phenethylamine

Preclinical safety-pharm

ADHD · Cognitive fatigue

CRO — Allschwil

NGP-214

Tropane analog

Discovery

Narcolepsy

In-house

NGP-330

Eugeroic (modafinil-class)

Phase I (partner)

Shift-work sleep disorder

EU Consortium

NGP-402

Modafinil analog

IND-enabling

Treatment-resistant depression

In-house

NGP-518

2-Aminoindane

Discovery

Cognitive decline (aging)

ETH Zürich (grant)

NGP-621

Cathinone chemotype

Preclinical

Binge-eating disorder

In-house

Phenethylamines·Tropanes·Eugeroics·Aminoindanes·Phenethylamines·Tropanes·Eugeroics·Aminoindanes·

Compound classes

Mechanism of action

CLASS · IR-C6H4-CH2-CH(NH2)-CH3

Phenethylamines

Our phenethylamine program pursues selective monoamine releasers with reduced peripheral sympathomimetic burden. NGP-107 introduces an α-methyl substitution stabilising the aminergic backbone against MAO-A while preserving DAT/NET selectivity in HEK-293 uptake assays (IC50 = 118 ± 12 nM for DAT, > 4,200 nM for SERT).

MoA · Substrate-type releaser at DAT/NET; negligible SERT activity.

CLASS · II8-methyl-8-azabicyclo[3.2.1]octane core

Tropane analogs

Bicyclic tropane frameworks act as high-affinity DAT reuptake inhibitors. Program NGP-214 modifies the 3β-aryl ester to shift binding kinetics toward slow-onset, atypical DAT inhibition — a profile hypothesised to lower abuse liability while retaining wakefulness and executive-function benefits.

MoA · Atypical DAT inhibition · slow onset · low reinforcement.

CLASS · IIIDiphenylmethyl-sulfinyl-acetamide scaffolds

Eugeroics

Modafinil-class eugeroics remain among the safest CNS wake-promoting agents in clinical use. Our NGP-330 and NGP-402 series introduce fluorinated aromatic substitutions to improve oral bioavailability (Papp > 22 × 10⁻⁶ cm/s, Caco-2) and increase half-life without shifting the receptor engagement profile.

MoA · Weak DAT inhibition · orexinergic and histaminergic modulation.

CLASS · IV2,3-dihydro-1H-inden-2-amine

2-Aminoindanes

The 2-aminoindane scaffold offers a conformationally restricted phenethylamine geometry with attenuated neurotoxicity in dopaminergic long-term cultures. NGP-518 explores 5,6-methylenedioxy analogs for cognition indications in an ETH Zürich collaborative grant.

MoA · Balanced NE/DA release · low serotonergic footprint.

Selected abstracts

Internal reports · 2024–2025

ABS-001

NewGenPharma Preclinical Reports · Vol. II · 2024

Weber M., Rohner K., Amstad L., Béguelin P.

Selective DAT/NET releasing activity of α-methylated phenethylamines in a modified HEK-293 uptake assay.

We characterise a series of eleven α-methyl-substituted phenethylamines (NGP-107-a to k) in an in vitro monoamine uptake assay using HEK-293 cells stably transfected with human DAT, NET, or SERT. Compounds were profiled for IC50 potency, cytotoxicity (MTS, 48 h) and selectivity ratios. Lead compound NGP-107 exhibited IC50(DAT) = 118 ± 12 nM, IC50(NET) = 89 ± 9 nM and IC50(SERT) > 4,200 nM, establishing a > 35-fold selectivity window over the serotonergic system. In parallel MAO-A microsomal assays, α-methylation reduced MAO-mediated turnover by 71 % relative to reference d-amphetamine, consistent with the hypothesised backbone stabilisation.

ABS-002

NewGenPharma Preclinical Reports · Vol. II · 2024

Béguelin P., Iselin V., Rohner K.

Fluorinated modafinil analogs with improved Caco-2 permeability and hepatic microsomal stability.

A focused library of eighteen fluorinated diphenylmethyl-sulfinyl-acetamide analogs (NGP-330/402 series) was evaluated for Caco-2 apparent permeability, human liver microsomal stability (HLM t½), and P-gp efflux liability. Fluorination at the ortho-position of both aromatic rings improved Papp from 14.1 to 22.7 × 10⁻⁶ cm/s and extended HLM t½ from 46 min to > 120 min. Efflux ratios remained within acceptable industry ranges (BA:AB < 2.1). These properties support once-daily oral dosing in a shift-work sleep disorder indication.

ABS-003

NewGenPharma Process Chemistry Notes · No. 07 · 2025

Amstad L., Frei D., Sutter M.

Process-scale synthesis of a tropane 3β-aryl ester API intermediate under continuous-flow conditions.

We report a continuous-flow variant of the classical Robinson tropinone condensation adapted to the synthesis of the NGP-214 intermediate 3β-(4-chlorophenyl)-tropane-2β-carboxylic acid methyl ester. Operating at 82 °C with a residence time of 9.4 min, the flow process delivers 92.3 % isolated yield at kilogram scale with an enantiomeric excess of 99.1 %. ICH-Q3D residual metals are within Class 2A limits (Pd < 8 ppm, Ni < 12 ppm). A full DMF-ready dossier is available under NDA.

§ Documentation Standards

Every gram, accounted for.

We'll email an NDA + dossier link within seconds.

CoACertificate of Analysis — HPLC-UV / HPLC-MS / KF / ICP-MS
ICHQ3A · Q3B · Q3C · Q3D residual profiles
DMFDrug Master File-ready dossiers, U.S. FDA & EMA formats
QMSISO 9001:2015 · Swissmedic GMP alignment
BatchCp/Cpk statistical process capability with each lot

§ Research portalPeer-reviewed literature grounding our programs

Citations & further reading.

The claims we make in our compound descriptions and abstracts trace back to published, peer-reviewed evidence. The list below is a curated starting point for anyone who wants to investigate our scientific positions directly. Every entry links out to the primary source.

§01

Modafinil-class eugeroics · safety and mechanism

[1]
Ballon JS, Feifel D. A systematic review of modafinil: potential clinical uses and mechanisms of action. J Clin Psychiatry. 2006;67(4):554-566. doi:10.4088/jcp.v67n0406 ↗
[2]
Volkow ND, Fowler JS, Logan J, et al. Effects of modafinil on dopamine and dopamine transporters in the male human brain: clinical implications. JAMA. 2009;301(11):1148-1154. doi:10.1001/jama.2009.351 ↗
[3]
Turner DC, Robbins TW, Clark L, et al. Cognitive enhancing effects of modafinil in healthy volunteers. Psychopharmacology. 2003;165(3):260-269. doi:10.1007/s00213-002-1250-8 ↗
[4]
Wisor J. Modafinil as a catecholaminergic agent: empirical evidence and unanswered questions. Front Neurol. 2013;4:139. doi:10.3389/fneur.2013.00139 ↗
[5]
Goss AJ, Kaser M, Costafreda SG, Sahakian BJ, Fu CH. Modafinil augmentation therapy in unipolar and bipolar depression: a systematic review and meta-analysis of randomized controlled trials. J Clin Psychiatry. 2013;74(11):1101-1107. doi:10.4088/JCP.13r08560 ↗

§02

Atypical DAT inhibitors · tropane pharmacology

[1]
Reith MEA, Blough BE, Hong WC, et al. Behavioral, biological, and chemical perspectives on atypical agents targeting the dopamine transporter. J Med Chem. 2015;58(21):8515-8531. doi:10.1021/acs.jmedchem.5b00003 ↗
[2]
Loland CJ, Mereu M, Okunola OM, et al. R-modafinil (armodafinil): a unique dopamine uptake inhibitor and potential medication for psychostimulant abuse. Biol Psychiatry. 2012;72(5):405-413. doi:10.1016/j.biopsych.2012.03.022 ↗
[3]
Newman AH, Ku T, Jordan CJ, Bonifazi A, Xi ZX. New drugs, old targets: tweaking the dopamine system to treat psychostimulant use disorders. Annu Rev Pharmacol Toxicol. 2021;61:609-628. doi:10.1146/annurev-pharmtox-030220-124205 ↗

§03

Phenethylamines and monoamine transporter pharmacology

[1]
Sitte HH, Freissmuth M. Amphetamines, new psychoactive drugs and the monoamine transporter cycle. Trends Pharmacol Sci. 2015;36(1):41-50. doi:10.1016/j.tips.2014.11.006 ↗
[2]
Rothman RB, Baumann MH. Monoamine transporters and psychostimulant drugs. Eur J Pharmacol. 2003;479(1-3):23-40. doi:10.1016/j.ejphar.2003.08.054 ↗
[3]
Heal DJ, Smith SL, Gosden J, Nutt DJ. Amphetamine, past and present — a pharmacological and clinical perspective. J Psychopharmacol. 2013;27(6):479-496. doi:10.1177/0269881113482532 ↗

§04

2-Aminoindanes · conformationally-restricted phenethylamines

[1]
Nichols DE, Brewster WK, Johnson MP, Oberlender R, Riggs RM. Nonneurotoxic tetralin and indan analogues of 3,4-(methylenedioxy)amphetamine. J Med Chem. 1990;33(2):703-710. doi:10.1021/jm00164a037 ↗
[2]
Pinterova N, Horsley RR, Palenicek T. Synthetic aminoindanes: a summary of existing knowledge. Front Psychiatry. 2017;8:236. doi:10.3389/fpsyt.2017.00236 ↗

§05

Cathinones, appetite modulation and binge-eating disorder

[1]
McElroy SL, Hudson JI, Mitchell JE, et al. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72(3):235-246. doi:10.1001/jamapsychiatry.2014.2162 ↗
[2]
Kelly JP. Cathinone derivatives: a review of their chemistry, pharmacology and toxicology. Drug Test Anal. 2011;3(7-8):439-453. doi:10.1002/dta.313 ↗

§06

Shift-work sleep disorder and wakefulness pharmacology

[1]
Åkerstedt T, Wright KP Jr. Sleep loss and fatigue in shift work and shift work disorder. Sleep Med Clin. 2009;4(2):257-271. doi:10.1016/j.jsmc.2009.03.001 ↗

§07

Medicinal chemistry — fluorine, permeability, ADME

[1]
Purser S, Moore PR, Swallow S, Gouverneur V. Fluorine in medicinal chemistry. Chem Soc Rev. 2008;37(2):320-330. doi:10.1039/b610213c ↗

This bibliography is illustrative and non-exhaustive. Additional references — including unpublished internal reports and DMF-supporting analytical data — are available to partners under a mutual NDA. Corrections or additions: press@newgenpharma.ch.