MedPath

Aloe vera leaf

Generic Name
Aloe vera leaf
Brand Names
Alcortin A, Aloquin
Drug Type
Biotech
CAS Number
8001-97-6
Unique Ingredient Identifier
ZY81Z83H0X

Overview

Aloe describes a genus including over 500 species of flowering succulent plants that grow in the Southern peninsula and various islands. Aloe vera, or Aloe barbadensis miller, is the most common species of Aloe that is cultivated for agricultural and medical purposes. It is a perennial succulent xerophyte with elongated leaves that contain a clear gel. While aloe vera has a long history of commercial uses, it is still widely used in cosmetic, food and pharmaceutical products. The use of aloe vera in constipation, inflammatory disorders, cancer, ulcer, and diabetes has also been investigated . The active constituents of aloe vera include polysaccharides with protective effects on skin, as they exhibit antioxidant and anti-inflammatory properties . Common active polysaccharides include glucomannans, polymannose, and acemannan, or b-(1–4)-acetylated polymannose . Acemannan and other modified polysaccharides are responsible in preventing suppression of contact hypersensitivity or immune suppression induced by external factors such as irradiation .

Indication

Indicated for use as a topical agent to soothe sensitive skin and to relieve symptoms of various skin conditions, including contact or atopic dermatitis, eczema, dermatitis and acne urticata, first- and second-degree burns, radiation dermatitis, and sunburn.

Associated Conditions

  • Acne
  • Atopic Dermatitis
  • Contact dermatitis and other eczema
  • Dermatosis
  • Folliculitis
  • Intertrigo
  • Lichen simplex chronicus
  • Moniliasis
  • Nummular Dermatitis
  • Pruritus Ani
  • Pyoderma
  • Stasis dermatitis
  • Disseminated Neurodermatitis
  • Genital pruritus
  • Localized Neurodermatitis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/17
Phase 4
Completed
2025/03/06
Phase 1
Completed
Minia University
2024/02/06
Not Applicable
Completed
Islamabad Medical and Dental College
2023/09/18
Phase 4
Completed
2021/02/15
Not Applicable
Completed
Ospedale Sandro Pertini, Roma
2020/12/10
Phase 2
Completed
Zainab J Abbas
2019/07/05
Not Applicable
Completed
2017/06/29
Phase 2
Completed
Government Dental College and Research Institute, Bangalore
2017/04/11
Phase 2
UNKNOWN
2016/06/30
Phase 1
Withdrawn

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Newton Laboratories, Inc.
55714-2596
ORAL
15 [hp_X] in 1 mL
5/21/2025
Newton Laboratories, Inc.
55714-4862
ORAL
15 [hp_X] in 1 mL
5/21/2025
Primus Pharmaceuticals
68040-706
TOPICAL
10 mg in 1 g
10/7/2009
Primus Pharmaceuticals
68040-705
TOPICAL
10 mg in 1 g
10/30/2009
Syntenza Pharmaceuticals LLC
72056-020
TOPICAL
10 mg in 1 g
5/6/2020
Guangzhou Yapeng Refinement Chemical Co., Ltd.
84356-007
TOPICAL
13 g in 100 g
6/20/2025
Deseret Biologicals, Inc.
43742-2276
ORAL
8 [hp_X] in 1 mL
5/7/2025
Newton Laboratories, Inc.
55714-4838
ORAL
15 [hp_X] in 1 mL
5/21/2025
Shanghai Tongjie Commodity Co.,Ltd.
85511-001
TOPICAL
10 mg in 100 mg
4/9/2025
King Bio Inc.
57955-1814
ORAL
12 [hp_X] in 236 mL
5/20/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SANKAIJO TABLET
SIN03486P
TABLET, FILM COATED
12.5 mg
6/24/1989

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
HOMEOPATHIC MEDICINE (S NO. 249) DPS 30C
total health centre
02077043
Drops - Oral
30 C / ML
12/31/1994
UNDA 46
seroyal international inc.
02233262
Liquid ,  Drops ,  Granules ,  Pellet ,  Tablet - Oral
10 X
4/6/1998
SEPIA COMPOSE DPS
laboratoires holis inc.
01934422
Drops - Oral
3 CH / DH
12/31/1984
ALOE SOCOTRINA GRANULE 1DH-30DH
homeocan inc.
00855545
Tablet - Oral
1 DH
12/31/1991
ALOE
seroyal international inc.
02233083
Drops ,  Tablet ,  Liquid ,  Pellet ,  Granules ,  Globules - Oral
1 X
4/6/1998
ALOE GOUTTE 4CH-30CH
dolisos laboratoires s.a.
00680486
Drops - Oral
2 CH / CH
12/31/1987
ONE TIME COMPOUND BENZOIN TCT F466
ACME UNITED CORPORATION
00518301
Stick - Topical
2 %
12/31/1979
HP5 TAB
01975870
Tablet - Oral
3 X
10/4/1996
ALSIDOZ TAB
alsi cie ltee
00393665
Tablet - Oral
16.25 MG
12/31/1977
ALOE GRANULE 1DH - 30CH
dolisos laboratoires s.a.
00698962
Tablet - Oral
1 DH / DH
12/31/1987

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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