minocycline extended release / Generic mfg. - LARVOL DELTA

Impact of Low-Dose Oral Minocycline (DFD-29) on Skin, Gastrointestinal, and Vaginal Microflora in Healthy Adults. (PubMed, J Drugs Dermatol) - "Administration of DFD-29 for 16 weeks had no detectable effects on skin, GI tract, or vaginal microflora and was well tolerated in healthy adults, reinforcing its potential as a therapeutic option in moderate-to-severe rosacea. &nbsp."

Clinical • Journal • Dermatology • Gastrointestinal Disorder • Rosacea

Efficacy and safety of oral DFD-29, a low-dose formulation of minocycline versus doxycycline in rosacea: A systematic review and meta-analysis of randomized placebo-controlled trials (EADV 2025) - "In cases where rosacea is not adequately controlled with sub- antimicrobial dosing with doxycycline, evaluating the efficacy and safety of an alternative tetracycline class of sub- antimicrobial treatment, minocycline, will expand therapeutic options to treat rosacea. In conclusion, our meta-analysis showed that DFD-29, a sub-antimicrobial extended-release formulation of minocycline, at 40 mg daily, is a superior and well-tolerated alternative to sub-antimicrobial dosing of doxycycline for moderate-to-severe papulopustular rosacea."

Retrospective data • Review • Atrial Fibrillation • Cardiovascular • Dermatology • Rosacea

Doxycycline 40 mg vs. DFD-29 40 mg for Rosacea Treatment: A Meta-Analysis of Three Randomized Controlled Trials (EADV 2025) - "Recent randomized controlled trials (RCTs) have demonstrated the efficacy of DFD-29, a minocycline extended-release oral capsule, as a novel treatment option. DFD-29 (40 mg) may offer superior efficacy and safety compared to doxycycline (40 mg) for the treatment of rosacea. However, our findings should be interpreted with caution due to potential heterogeneity, which may stem from variations in rosacea subtypes and severity, as well as the limited sample size. Future randomized controlled trials (RCTs) are warranted to further clarify the potential superiority of DFD-29, particularly in specific rosacea subtypes."

Retrospective data • Dermatology • Inflammation • Rosacea

STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Active, not recruiting

Enrollment closed • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

IGNITE: Evaluating the Role of Neuroinflammation in Low Back Pain (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Marco Loggia | N=89 ➔ 60

Enrollment change • Back Pain • Inflammation • Lumbar Back Pain • Musculoskeletal Pain • Pain

BASS: Brain and Stress Study (clinicaltrials.gov) - P4 | N=10 | Completed | Sponsor: University of North Carolina, Chapel Hill | N=18 ➔ 10

Enrollment change

Prevention of Treatment Induced Neuropathy in Multiple Myeloma (clinicaltrials.gov) - P2 | N=79 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology • Pain

IGNITE: Evaluating the Role of Neuroinflammation in Low Back Pain (clinicaltrials.gov) - P2 | N=89 | Completed | Sponsor: Marco Loggia | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Inflammation • Lumbar Back Pain • Musculoskeletal Pain • Pain

BASS: Brain and Stress Study (clinicaltrials.gov) - P4 | N=18 | Completed | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Completed | N=38 ➔ 18

Enrollment change • Trial completion

STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Aug 2023 ➔ Aug 2025

Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

IGNITE: Evaluating the Role of Neuroinflammation in Low Back Pain (clinicaltrials.gov) - P2 | N=89 | Active, not recruiting | Sponsor: Marco Loggia | Recruiting ➔ Active, not recruiting | N=145 ➔ 89 | Trial completion date: Sep 2022 ➔ Apr 2024 | Trial primary completion date: Sep 2022 ➔ Apr 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Back Pain • Inflammation • Lumbar Back Pain • Musculoskeletal Pain • Pain

Drugs for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris

BASS: Brain and Stress Study (clinicaltrials.gov) - P4 | N=38 | Recruiting | Sponsor: University of North Carolina, Chapel Hill

New P4 trial

Confluent and Reticulated Papillomatosis Treated with Extended-Release Minocycline. (PubMed, Indian Dermatol Online J) - No abstract available

Journal • Oncology

Minocycline in the Treatment of Angelman Syndrome (clinicaltrials.gov) - P=N/A | N=25 | Completed | Sponsor: University of South Florida | Unknown status ➔ Completed

Trial completion • UBE3A

Minocycline to reduce cancer pain in patients with multiple myeloma: A phase II randomized trial. (ASCO 2017) - P2; "Minocycline during maintenance therapy for MM was feasible, had a low toxicity profile, and yielded a statistically significant positive signal on pain reduction. These preliminary results are encouraging and warrant a Phase III trial to test its efficacy."

Clinical • P2 data • Biosimilar • Demo Pain • Multiple Myeloma • Pain

A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Journey Medical Corporation | Active, not recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ May 2022 | Trial primary completion date: Sep 2022 ➔ May 2022

Trial completion • Trial completion date • Trial primary completion date

STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer (clinicaltrials.gov) - P2 | N=30 | Terminated | Sponsor: M.D. Anderson Cancer Center | Completed ➔ Terminated; Early termination due to the protocol lack of progress in improving accrual rate

Trial termination • Head and Neck Cancer • Oncology • Solid Tumor

Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Aug 2022 | Trial primary completion date: Dec 2022 ➔ Aug 2022

Trial completion • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor

A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Journey Medical Corporation

New P1 trial

Prevention of Treatment Induced Neuropathy in Multiple Myeloma (clinicaltrials.gov) - P2 | N=79 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2023 ➔ Apr 2023 | Trial primary completion date: Jan 2023 ➔ Apr 2023

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Pain

Prevention of Treatment Induced Neuropathy in Multiple Myeloma (clinicaltrials.gov) - P2 | N=79 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2022 ➔ Jan 2023 | Trial primary completion date: Jan 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Pain

Minocycline Extended-Release Comparison with Doxycycline for the Treatment of Rosacea: A Randomized, Head-to-Head, Clinical Trial. (PubMed, J Clin Aesthet Dermatol) - P2 | "MIC values and plasma concentrations shown for antibacterial threshold data are mean values; fast absorbers/slow metabolizers could exceed the threshold, causing resistance selection pressure. DFD-29 40mg demonstrated significantly greater efficacy than placebo, DFD-29 20mg, and doxycycline 40mg at plasma concentrations predicted to be below the antimicrobial threshold for the treatment of PPR."

Head-to-Head • Journal • Dermatology • Rosacea

Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer (clinicaltrials.gov) - P2; N=30; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor