IP Library › Granted Patent US 12,246,005
Granted Patent B2
US 12,246,005 · App. 18/607,093 · Granted Mar 11, 2025

5-methoxy-n,n-dimethyltryptamine (5-MeO-DMT) formulations

Inventor: Jason Gray (Oxford, GB)
Assignee: Beckley Psytech Limited
A61K31/4045A61K9/0043A61K9/1611A61K9/1623A61K9/1652A61K9/19A61M15/08
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Quick Facts
Patent No.
US 12,246,005
App. No.
18/607,093
Granted
Mar 11, 2025
Kind
B2
Abstract

The present invention provides a dry powder formulation of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carriers or excipients. The formulations described herein may be used to treat a disease or condition, such as depression or alcohol use disorder in a subject in need thereof.

Claims (20)

1. A dry blended free-flowing dry powder pharmaceutical formulation comprising 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), or a pharmaceutically acceptable salt thereof, and silicon dioxide.

2. The dry blended free-flowing dry powder pharmaceutical formulation of claim 1 , wherein the formulation comprises from 40% to 60% 5-MeO-DMT by weight.

3. The dry blended free-flowing dry powder pharmaceutical formulation of claim 1 , wherein the formulation comprises methyl cellulose.

4. The dry blended free-flowing dry powder pharmaceutical formulation of claim 1 , wherein the formulation comprises a low viscosity methyl cellulose and a high viscosity methyl cellulose.

5. The dry blended free-flowing dry powder pharmaceutical formulation of claim 1 , wherein the formulation comprises a cellulose like or based excipient.

6. The dry blended free-flowing dry powder pharmaceutical formulation of claim 4 , wherein the formulation comprises a low viscosity hydroxypropyl methyl cellulose (HPMC) and a high viscosity HPMC.

7. The dry blended free-flowing dry powder pharmaceutical formulation of claim 6 , wherein the ratio of the low viscosity HPMC to high viscosity HPMC is in the ratio of 1:10 to 10:1.

8. The dry blended free-flowing dry powder pharmaceutical formulation of claim 6 , wherein the ratio of the low viscosity HPMC to high viscosity HPMC is in the ratio of between 50:50 and 25:75.

9. The dry blended free-flowing dry powder pharmaceutical formulation of claim 8 , wherein the high viscosity HPMC has a viscosity characterized as greater or equal to about 20 millipascal-second (mPa⋅s) where the HPMC is a HPMC comprising about 7.0-12.0% hydroxypropyl content, about 28.0-30.0% methoxy content, and a viscosity of about 50 mPa⋅s.

10. The dry blended free-flowing dry powder pharmaceutical formulation of claim 8 , wherein the low viscosity HPMC has a viscosity characterized as less than about 20 millipascal-second (mPa⋅s) where the HPMC is a HPMC comprising about 7.0-12.0% hydroxypropyl content, about 28.0-30.0% methoxy content, and a viscosity of about 4.8-7.2 mPa⋅s.

11. The dry blended free-flowing dry powder pharmaceutical formulation of claim 1 , wherein the formulation comprises a polyol.

12. The dry blended free-flowing dry powder pharmaceutical formulation of claim 11 , wherein the formulation comprises about 1-10% polyol by weight.

13. The dry blended free-flowing dry powder pharmaceutical formulation of claim 12 , wherein the formulation comprises about 3% sorbitol, mannitol, or isomalt by weight.

14. The dry blended free-flowing dry powder pharmaceutical formulation of claim 12 , wherein the formulation comprises about 3% sorbitol by weight.

15. The dry blended free-flowing dry powder pharmaceutical formulation of claim 1 , wherein the formulation comprises from about 1% w/w to about 10% w/w silicon dioxide.

16. The dry blended free-flowing dry powder pharmaceutical formulation of claim 15 , wherein the formulation comprises 5-MeO-DMT benzoate.

17. The dry blended free-flowing dry powder pharmaceutical formulation of claim 15 , wherein the formulation comprises 5-MeO-DMT hydrochloride.

18. The dry blended free-flowing dry powder pharmaceutical formulation of claim 15 , wherein the formulation comprises 5-MeO-DMT hydrobromide.

19. The dry blended free-flowing dry powder pharmaceutical formulation of claim 15 , wherein the 5-MeO-DMT salt is amorphous.

20. The dry blended free-flowing dry powder pharmaceutical formulation of claim 15 , wherein the 5-MeO-DMT salt is crystalline.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2024
From: GRAY, JASON
To: BECKLEY PSYTECH LIMITED
Reel/Frame 067239/0305 →
Priority Claims (5)
GB 2308830 · Jun 13, 2023 · national
GB 2314993 · Sep 29, 2023 · national
GB 2315176 · Oct 3, 2023 · national
GB 2316902 · Nov 3, 2023 · national
GB 2400703 · Jan 18, 2024 · national
Continuity (2)
Continuation In Part 18229041 · Aug 1, 2023
Related Publication 20240415811A1 · Dec 19, 2024
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“Beckley Psytech Announces First Cohort of Psychotherapists Have Begun Training for Treatment Resistant Depression Phase 2 Trials,” Jan. 24, 2022. https://www.businesswire.com/news/home/20220123005101/en/Beckley-Psytech… [cited by applicant]
“Beckley Psytech Announces First Participant Dosed in Phase I Trial of ELE-101, A Novel Intravenous Formulation of Psilocin,” Nov. 9, 2022. https://www.businesswire.com/news/home/20221108005986/en/Beckley-Psytech-Announ… [cited by applicant]
“Beckley Psytech announces first patient has received low-dose psilocybin in world-first clinical trial for rare headache disorder,” Beckley Psytech Press Release Sep. 14, 2021 (5 pages). [cited by applicant]
“Beckley Psytech announces initial results from Phase I study and first patients dosed in Phase IIa study of ELE-101 (IV psilocin benzoate) for Major Depressive Disorder,” Beckley Psytech Press Release Jun. 20, 2024 (7 … [cited by applicant]
“Beckley Psytech Announces Partnership With Empatica in Latest Step of Digital Strategy, Designed to Deliver Personalised Patient Care,” May 19, 2022. https://www.businesswire.com/news/home/20220518006041/en/Beckley-Psy… [cited by applicant]
“Beckley Psytech Announces Partnership With Ksana Health, Building on Digital Strategy to Deliver Optimised Patient Outcomes,” Jun. 14, 2022. https://www.businesswire.com/news/home/20220613005701/en/Beckley-Psytech-Anno… [cited by applicant]
“Beckley Psytech announces positive initial data from Phase IIa study of novel 5-MeO-DMT formulation BPL-003 for Treatment Resistant Depression,” Mar. 27, 2024. https://www.businesswire.com/news/home/20240326357401/en/B… [cited by applicant]
“Beckley Psytech announces strategic investment from atai Life Sciences to accelerate the clinical development of short-duration psychedelics,” Beckley Psytech Press Release Jan. 4, 2024 (10 pages). [cited by applicant]
“Beckley Psytech announces £14m raise to conduct clinical trials on psychedelic medicine pipeline,” Beckley Psytech Press Release Dec. 22, 2020 (5 pages). [cited by applicant]
“Beckley Psytech applies for B Corporation status as part of its commitment to have a positive impact on society,” Beckley Psytech Press Release Dec. 21, 2021 (5 pages). [cited by applicant]
“Beckley Psytech appoints Dr Rob Hershberg to its Board of Directors,” Beckley Psytech Press Release Jun. 24, 2024 (6 pages). [cited by applicant]
“Beckley Psytech Bolsters Pipeline of Next-Generation Psychedelic Medicines With Research Collaboration and Strengthening of Relationship With Lophora ApS,” May 11, 2022. https://www.beckleypsytech.com/posts/beckley-psy… [cited by applicant]
“Beckley Psytech completes oversubscribed $80m (£58m) fundraise to develop portfolio of psychedelic medicine breakthroughs,” Beckley Psytech Press Release Aug. 15, 2021 (3 pages). [cited by applicant]
“Beckley Psytech grows team with new Clinical Operations and Communications hires,” Beckley Psytech Press Release Oct. 18, 2022 (4 pages). [cited by applicant]
“Beckley Psytech initiates Phase IIa study of 5-MeO-DMT candidate BPL-003 for Alcohol Use Disorder,” Apr. 5, 2023. https://www.businesswire.com/news/home/20230405005132/en/Beckley- Psytech-initiates-Phase-IIa-study-of-5… [cited by applicant]
“Beckley Psytech Launches Phase lla Study of Lead Candidate BPL-003, a Novel Benzoate Formulation of 5-MeO-DMT, for Treatment Resistant Depression,” Dec. 21, 2022. https://www.businesswire.com/news/home/20221221005221/e… [cited by applicant]
“Beckley Psytech publishes peer-reviewed paper on 5-MeO-DMT in Journal of Psychopharmacology, ” Beckley Psytech Press Release Feb. 22, 2022 (4 pages). [cited by applicant]
“Beckley Psytech receives approval for clinical trial using psychedelic agent to treat severe headache condition, ” Beckley Psytech Press Release Jan. 27, 2021 (4 pages). [cited by applicant]
“Beckley Psytech receives FDA Investigational New Drug (IND) approval for Phase IIb study of BPL-003, a novel synthetic formulation of 5-MeO-DMT (Mebufotenin),” Feb. 21, 2023. https://www.businesswire.com/news/home/2023… [cited by applicant]
“Beckley Psytech Strengthens Pipeline and Development Team With Acquisition of Eleusis Therapeutics Limited,” Oct. 24, 2022. https://www.businesswire.com/news/home/20221023005029/en/Beckley-Psytech-Strengthens-Pipeline-… [cited by applicant]
“Beckley Psytech Strengthens Senior Leadership Team With Appointment of Dr. Laura Trespidi as Chief Development Officer,” May 24, 2022. https://www.businesswire.com/news/home/20220523005870/en/Beckley-Psytech-Strengthen… [cited by applicant]
“Beckley Psytech Successfully Completes Phase I Clinical Study of Lead Candidate BPL-003, a Novel Benzoate Formulation Of 5-MeO-DMT,” Nov. 15, 2022. https://www.businesswire.com/news/home/20221114005907/en/Beckley-Psyte… [cited by applicant]
“Beckley Psytech to attend 11th Annual LifeSci Partners Virtual Corporate Access Event,” Dec. 8, 2021. https://www.businesswire.com/news/home/20211207006217/en/Beckley-Psytech-to-attend-11th-Annual-LifeSci-Partners-Virt… [cited by applicant]
“Beckley Psytech to Attend and Present at 8th Annual LSX World Congress 2022,” Apr. 13, 2022. https://www.businesswire.com/news/home/20220412005773/en/Beckley-Psytech-to-Attend-and-Present-at-8th-Annual-LSX-World-Congre… [cited by applicant]
“Beckley Psytech to Attend and Present at the Jefferies London Healthcare Conference—Nov. 15-17, 2022,” Nov. 4, 2022. https://www.businesswire.com/news/home/20221104005095/en/Beckley-Psytech-to-Attend-and-Present-at-the… [cited by applicant]
“Beckley Psytech to participate in Canaccord Genuity's Symposium on New Paradigms and Treatment Approaches in Mental Health—Dec. 13, 2022,” Beckley Psytech Press Release Dec. 7, 2022 (4 pages). [cited by applicant]
“Beckley Psytech to Present at 32nd Annual Oppenheimer Healthcare Conference,” Mar. 10, 2022. https://www.businesswire.com/news/home/20220309005837/en/Beckley-Psytech-to-Present-at-32nd-Annual-Oppenheimer-Healthcare-Con… [cited by applicant]
“Beckley Psytech to present at H.C. Wainwright 2nd Annual Psychedelics Conference and Stifel 2nd Annual Conference “The Future of Healthcare”,” Dec. 2, 2021. https://www.businesswire.com/news/home/20211201006018/en/Beck… [cited by applicant]
“Beckley Psytech to present at Jefferies 2021 London Healthcare Conference,” Nov. 2, 2021. https://www.businesswire.com/news/home/20211102005131/en/Beckley-Psytech-to-present-at-Jefferies-2021-London-Healthcare-Conferen… [cited by applicant]
“Beckley Psytech to present data from Phase I study of BPL-003, a novel synthetic formulation of 5-MeO-DMT (Mebufotenin), at upcoming scientific conference,” Beckley Psytech Press Release Apr. 24, 2023 (5 pages). [cited by applicant]
“Beckley Psytech's Phase I study results of novel 5-MeO-DMT formulation BPL-003 published in The Journal of Psychopharmacology,” Beckley Psytech Press Release Apr. 17, 2024 (6 pages). [cited by applicant]
“Brunch with Sifted: Amanda Feilding and Cosmo Feilding-Mellen on the psychedelic renaissance,” Beckley Psytech Press Release Nov. 24, 2021 (13 pages). [cited by applicant]
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“Dr Frank Wiegand, Experienced Neuroscience Leader Joins Beckley Psytech as Chief Medical Officer,” Nov. 3, 2021. https://www.businesswire.com/news/home/20211103005056/en/Dr-Frank-Wiegand-Experienced-Neuroscience-Leader… [cited by applicant]
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“First participant dosed in research study investigating the effects of BPL-003, a novel formulation of 5-MeO-DMT, on the human brain,” Beckley Psytech Press Release Jun. 3, 2024 (6 pages). [cited by applicant]
“First patient dosed in Beckley Psytech's international Phase IIb study of BPL-003, a novel synthetic intranasal formulation of 5-MeO-DMT, for Treatment Resistant Depression (TRD),” Beckley Psytech Press Release Oct. 24… [cited by applicant]
“First Patient Dosed in Beckley Psytech's Phase lla Study of BPL-003 for Treatment Resistant Depression,” May 4, 2023. https://www.businesswire.com/news/home/20230504005020/en/First-Patient-Dosed-in-Beckley-Psytech%E2%8… [cited by applicant]
“First patient dosed in Beckley Psytech's Phase IIa study of BPL-003 in combination with SSRIs for Treatment Resistant Depression,” Beckley Psytech Press Release Apr. 24, 2024 (6 pages). [cited by applicant]
“Former GW Pharmaceuticals CFO joins Beckley Psytech's Board,” Beckley Psytech Press Release Apr. 13, 2021 (4 pages). [cited by applicant]
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“Learning from 50 years of psychedelic progress,” Psytech Press Release Oct. 19, 2020 (6 pages). [cited by applicant]
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